31 results about "Rosuvastatin Calcium" patented technology

The invention provides a compound ezetimibe and rosuvastatin calcium tablet and a preparation method thereof.The preparation method comprises the steps that ezetimibe particles are prepared through a wet granulation method, rosuvastatin calcium particles are obtained through direct mixing, then the ezetimibe particles serve as a first layer, the rosuvastatin calcium particles serve as a second layer, an upper-layer tablet and a lower-layer tablet are prepared through a double-layer tablet press, and the upper-layer tablet and the lower-layer tablet are coated to obtain the compound ezetimibe and rosuvastatin calcium tablet. The compound ezetimibe rosuvastatin calcium tablet has the advantages of being stable in content, good in quality, high in stability and the like. The whole preparation method is simple, efficient, cost-saving and more suitable for commercial batch production.

The invention relates to a method for preparing a rosuvastatin calcium intermediate, and belongs to the technical field of drug intermediate synthesis. The method comprises the following steps: under the protection of nitrogen, carrying out reflux reaction on raw materials including 4-fluorobenzaldehyde and ethyl 4-methyl-3-oxovalerate under the catalysis of piperidine acetate and a co-catalyst, and carrying out reduced pressure distillation recovery to obtain a compound shown as a formula V; dropwise adding 2-ethyl-2-isothiourea and a compound shown in a formula VI, carrying out cyclization reaction under a non-violent reflux condition, and then adding DDQ in batches for oxidation to obtain a compound shown in a formula IV; oxidizing the compound as shown in the formula IV, and immediately quenching by using saturated NaHCO3 after the reaction is finished to obtain a compound as shown in a formula III; the preparation method comprises the following steps: firstly, treating a compound shown as a formula III by using methylamine, and slowly dropwise adding methylsulfonyl chloride under ice bath temperature control to obtain a compound shown as a formula II; reducing the ester group of the compound shown in the formula II in anhydrous toluene by using DIBAL to obtain an alcohol intermediate; then, selective oxidation is performed to obtain a final product; the method integrally has the advantages of high product yield and purity, few byproducts and low production difficulty.

The invention belongs to the field of organic chemistry, and particularly relates to a synthesis method of a rosuvastatin calcium key intermediate, which comprises the following steps: (1) taking (S)-4-chloro-3-hydroxybutyric acid as a raw material, and performing condensation ester with methanol under the condition of an esterification reaction condensing agent to obtain a compound with a structural formula B, and (2) taking the compound with the structural formula B as a raw material, and under the alkaline condition, performing condensation ester reaction to obtain the rosuvastatin calcium key intermediate. The preparation method comprises the following steps: (1) carrying out a reaction with tert-butyl malonate to obtain a compound with a structural formula C, (3) adding glucose and alkali into the compound with the structural formula C as a raw material under an enzyme catalysis condition to obtain a chiral reduction product D, and (4) heating the compound with the structural formula D as a raw material in the presence of only 2, 2-dimethoxypropane to obtain the rosuvastatin calcium key intermediate with a structural formula V. According to the method, tert-butyl bromoacetate and metal organic reagents which are high in cost and difficult to treat are not used, and solvents acetone and acid catalysts are not used in the ketal reaction, so that the production cost is reduced, and the method is more environment-friendly and efficient.

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for determining related substances of ezetimibe rosuvastatin calcium tablets, impurities of the ezetimibe rosuvastatin calcium tablets are determined by high performance liquid chromatography, a chromatographic column filler is octadecylsilane chemically bonded silica, a mobile phase A is 0.08-0.12% phosphoric acid aqueous solution, a mobile phase B is a mobile phase C, a mobile phase D is a mobile phase C, a mobile phase D is a mobile phase C, and a mobile phase D is a mobile phase C; the volume ratio of the mobile phase B acetonitrile to the mobile phase B methanol is (92-98): (8-2); the flow velocity is 0.9-1.1 ml per minute, the column temperature is 30-40 DEG C, the detection wavelength is 240-244nm, and the temperature of a sample disc is 5 DEG C; the sample injection volume is 5 microliters. According to the determination method disclosed by the invention, process impurities and degradation impurities of ezetimibe and rosuvastatin calcium can be detected by adopting the same method, and the method is high in accuracy, good in stability, strong in durability, high in detection efficiency and low in cost.

The application discloses a rosuvastatin calcium intermediate and a preparation method thereof, and belongs to the technical field of medicinal chemistry and organic synthesis. + [R-CH(OH)-SO3] ‑ , wherein R is 4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl-N-methylsulfonamido)pyrimidin-5-yl, A + is Na + , K + or NH4 + . Pyrimidine-5-formaldehyde is reacted with a corresponding bisulfite in water and a water-miscible organic solvent, a reverse solvent is added, crystallization is performed by cooling, filtration and drying are performed to obtain a crystalline addition product; active pyrimidine-5-formaldehyde is converted into a crystalline bisulfite addition product, the degree of oxidation and other degradation reactions of an aldehyde group in a storage process is reduced, and the content retention rate of the intermediate under long-term and accelerated storage conditions is improved.

The invention relates to a detection method for related substances of a rosuvastatin calcium intermediate and application of the detection method, and provides a specific detection method for related substances of the rosuvastatin calcium intermediate as shown in a formula (I), an impurity 1 compound, an impurity 2 compound and an impurity 3 compound. Wherein the separation degrees of peak positions of the impurities (the impurity 1, the impurity 2 and the impurity 3) and the target intermediate (the compound of the formula (I)) are good (the separation degrees are all greater than 1.5, and the tailing factors are all between 0.8 and 1.8), the content of each impurity can be detected at a lower concentration, and the detection sensitivity is higher; the detection method is used for central control detection of the key intermediate of the rosuvastatin calcium, the detection efficiency is improved, and the method can be used for impurity attribution and detection of related substances of the key intermediate of the rosuvastatin calcium, and has positive effects and practical application values; in addition, the safety control of the rosuvastatin calcium medicine can be enhanced.

The invention relates to the technical field of medicine analysis, in particular to a method for measuring ezetimibe isomer impurities in ezetimibe rosuvastatin calcium tablets, which adopts high performance liquid chromatography to measure ezetimibe isomer impurities in the ezetimibe rosuvastatin calcium tablets, and adopts a polysaccharide derivative reversed-phase coating type chiral chromatographic column as a chromatographic column. The volume ratio of the mobile phase acetonitrile to the mobile phase water is (20-55): (45-80), the detection wavelength is 248 nm, the flow velocity is 0.3-0.4 ml per minute, the column temperature is 5-15 DEG C, and the sample size is 5-20 microliters. The ezetimibe and rosuvastatin calcium tablet isomer determination method provided by the invention can meet the separation of ezetimibe and enantiomer and diastereomer impurities thereof, and eliminates the interference of rosuvastatin calcium and isomer impurities thereof in a two-component preparation; the measuring method is good in system adaptability, linearity and range and high in accuracy and durability.

The application discloses a method for detecting the dissolution curve of ezetimibe and rosuvastatin calcium tablets, and belongs to the technical field of drug detection. The method uses an aqueous solution containing 0.1-0.3 wt% polysorbate 80 as a dissolution medium, and performs dissolution according to a dissolution instrument basket method, wherein the rotating speed of the rotating basket is 50-100 revolutions per minute, and the mesh number of the rotating basket is 10 meshes. The method provided by the application has good dissolution for both ezetimibe and rosuvastatin calcium, and has the characteristics of strong specificity, high sensitivity, high accuracy, good durability and the like, can effectively distinguish the difference between self-prepared preparations and reference preparations, and is more universal and practical, and is more simple and efficient in operation.

A solid pharmaceutical composition comprising amlodipine or its pharmaceutically acceptable salt, in particular amlodipine besylate, ramipril and rosuvastatin or its pharmaceutically acceptable salt, in particular rosuvastatin calcium, in a single dosage unit, a process for its preparation and a single dosage unit comprising it. The composition finds its use in the treatment of cardiovascular diseases.

The invention belongs to the technical field of organic synthesis, and discloses a ketene derivative as well as a preparation method and application thereof. A novel synthesis method is researched and developed, a strategy of catalytic reduction coupling reaction of cheap metal cobalt is adopted, cobalt bromide is used as a catalyst, terpyridyl is used as a ligand, zinc powder is used as a reducing agent, and dimethyl sulfoxide is used as a solvent to realize coupling addition. Aiming at the reaction conditions of the reaction, the four aspects of the catalyst, the reaction solvent, the ligand and the reaction temperature are confirmed and optimized. By researching and developing the novel synthesis method, the synthesis of the ketene derivative has wider universality, reaction conditions are milder, the reaction process is easier to operate and control, and the method is energy-saving, environment-friendly, economical and efficient. In addition, an intermediate of a medicine rosuvastatin calcium for treating cardiovascular diseases is synthesized by using the method, so that the intermediate has potential significance in industrial production. # imgabs0 #

The invention discloses a preparation method of rosuvastatin calcium tablets, and belongs to the field of pharmacy. The rosuvastatin calcium tablet comprises the following components: a raw material medicine: rosuvastatin calcium, and auxiliary materials: lactose, microcrystalline cellulose, hydrophobic colloidal silicon dioxide and magnesium stearate. The preparation method of the rosuvastatin calcium tablet comprises the steps of weighing according to the prescription amount, crushing and sieving pretreatment of the raw materials, sieving pretreatment of whole particles of the auxiliary materials, premixing, feeding and total mixing, tabletting and the like. The prepared rosuvastatin calcium tablet is relatively good in medicine quality, high in stability and relatively few in waste products.

The invention provides the preparation method of the ezetimibe and rosuvastatin calcium composition, which ensures the long-term stability of the preparation, is simple and convenient in process and is suitable for industrial production. According to the preparation method, conventional accessible equipment is adopted for preparation, key quality attributes of intermediate products in the preparation process are strictly controlled, the prepared finished product is stable in quality in the long-term storage process, and the total degradation product is smaller than 2.5% after the finished product is stored for 36 months.

The invention provides a preparation method of a rosuvastatin calcium intermediate, and belongs to the technical field of organic synthesis. (S)-4-chloro-3-hydroxybutyronitrile is used as a raw material, and the rosuvastatin calcium intermediate 2-(4R, 6S)-2, 2-dimethyl-6-[(5-methyl-1, 3, 4-thiazole-2-sulfonyl) methyl)-1, 3-dioxane] tert-butyl acetate (YD5-2) is synthesized through the steps of upper protection, addition, deprotection, chiral reduction, upper protection, addition, oxidation and the like. According to the preparation method of the rosuvastatin calcium intermediate, raw materials are easy to obtain, reaction conditions are mild, the safety coefficient is high, operability is high, the process is simple, industrialization is easy to achieve, and the product is high in purity and stable in quality.

The invention discloses a method for synthesizing rosuvastatin calcium tert-butyl ester. A Grignard reagent is synthesized by reacting a compound I with magnesium powder, the Grignard reagent is reacted with trimethylsilane under the action of a catalyst to prepare a compound III (4R-CIS)-6-trimethylsilyl-2,2-dimethyl-1,3-dioxane-4-acetic acid tert-butyl ester, the compound III reacts with a compound IV under the action of a catalyst to prepare a compound V, and the compound V is hydrolyzed under alkaline or acidic conditions to prepare rosuvastatin tert-butyl ester. The method has the following beneficial effects: compound III is prepared by reacting the Grignard reagent with trimethylsilane, the yield of the synthesis of the side chain of rosuvastatin calcium is improved, a cesium fluoride catalyst is selected for catalysis through a Peterson olefination reaction, the selectivity of the olefination reaction is effectively increased, and the generation of by-products and three wastes is reduced.

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses an ezetimibe and rosuvastatin calcium tablet and a preparation method thereof. According to the ezetimibe and rosuvastatin calcium tablet and the preparation method thereof, the ultrasonic modified microcrystalline cellulose with high specific surface area and high relative water retention value is added into the ezetimibe and rosuvastatin calcium tablet, ezetimibe can be well coated, in addition, the ultrasonic modified microcrystalline cellulose has more hydroxyl groups, and can form hydrogen bonds with the hydroxyl groups in the ezetimibe, so that the ezetimibe and rosuvastatin calcium tablet can be used for preparing the ezetimibe and rosuvastatin calcium tablet. The ezetimibe stably exists in the pore diameter of the ultrasonic modified microcrystalline cellulose, and the solubility of the ezetimibe can be effectively improved in the drug release process.

The application provides a nanocrystal drug composition containing rosuvastatin calcium, which contains the following components in parts by weight: 100 parts of rosuvastatin calcium, 20-150 parts of a stabilizer and 200-2000 parts of a pharmaceutically acceptable carrier; the stabilizer is composed of a steric hindrance stabilizer and an electrostatic stabilizer, and the weight ratio of the two is 1:0.5 to 1:2; in the nanocrystal drug composition, the average particle size of rosuvastatin calcium is distributed between 200 nm and 800 nm, and the polydispersity index (PDI) is less than 0.2; by using a specific stabilizer combination and a preparation process, the application prepares rosuvastatin calcium into a nanocrystal with an average particle size of 200 nm-800 nm, significantly improves the solubility and dissolution rate of the drug, and the nanocrystal drug composition exhibits excellent physical stability and chemical stability under accelerated test conditions, overcomes the problems that rosuvastatin calcium is unstable to light, moisture and heat and the bioavailability of existing preparations is limited, and has significant clinical application value.

The utility model discloses a rosuvastatin calcium tablet medicine taking reminding device, and particularly relates to the technical field of medicine taking reminding. The rosuvastatin calcium tablet taking reminding device comprises a reminding mechanism, a water storage mechanism is fixedly installed at the bottom of the reminding mechanism, a medicine storage mechanism is fixedly installed at the top of the water storage mechanism, the water storage mechanism comprises a base, and a water storage body is fixedly installed at the top of the base; the top of the water storage main body is in threaded connection with a top cover, a heating piece is fixedly installed at the top of the base, a pressure release valve is fixedly installed on one side of the top cover, liquid in the water storage main body is heated through the arranged heating piece, and after preset time is up, a user is reminded through an alarm clock; at the moment, a user takes medicine through the medicine storage mechanism and obtains hot water with the appropriate temperature through the water storage mechanism, the medicine taking process can be completed through the equipment, the user does not need to prepare other steps, and the user is prevented from forgetting at one step.

The invention relates to the technical field of medicine analysis, in particular to a method for determining an ezetimibe rosuvastatin calcium tablet isomer, and rosuvastatin calcium isomer impurities in an ezetimibe rosuvastatin calcium tablet are determined by adopting a high performance liquid chromatography. A chromatographic column is a polysaccharide derivative coating type chiral chromatographic column; a mobile phase A is a 0.08%-0.12% trifluoroacetic acid aqueous solution; the mobile phase B is acetonitrile; carrying out gradient elution; the flow velocity is 0.4-0.6 ml per minute; the column temperature is 23-27 DEG C; the detection wavelength is 240 to 244nm; the sample injection volume is 5-10 microliters. According to the method, separation of rosuvastatin calcium and isomer impurities thereof can be realized, interference of ezetimibe and isomer impurities thereof in a two-component preparation is eliminated, and the isomer impurities of rosuvastatin calcium are accurately detected.

The invention belongs to the field of pharmaceutical preparations, and discloses a rosuvastatin calcium quick release-slow release double-layer tablet preparation and a preparation process thereof. The preparation process comprises the following steps: (1) pretreating raw materials; (2) pretreating auxiliary materials; (3) preparing quick-release layer particles by adopting a supercritical nanocrystallization and carrier adsorption process; (4) preparing sustained-release layer particles: preparing amorphous quick-release layer particles of rosuvastatin calcium by adopting a hot-melt extrusion method in the preparation of the sustained-release layer particles; (5) total mixing of quick-release layer particles; (6) total mixing of sustained-release layer particles; (7) tabletting; and (8) coating with a film. According to the rosuvastatin calcium double-layer tablet prepared by creatively combining hot melt extrusion with a nanocrystal technology, the solubility and bioavailability are improved, the problems of low solubility and photo-thermal sensitivity of an existing preparation are effectively solved, and the preparation method is stable and suitable for large-scale preparation.

The present invention relates to the field of organic synthesis technology, and in particular to a preparation method of rosuvastatin calcium intermediate. The method includes mixing a reactant, a photocatalyst and a first organic solvent to form a reaction system; the reaction system is catalytically reacted under visible light irradiation conditions and an air environment to obtain a target product; the molar amount of the photocatalyst is 5% to 15% of the molar amount of the reactant; the reactant is 6-(4-fluorophenyl)-1,2-dihydro-4-(1-methylethyl)-2-oxo-5-tetrahydropyrimidinecarboxylic acid methyl esters; the photocatalyst is a dye photocatalyst; the target product is 6-(4-fluorophenyl)-1,2-dihydro-4-(1-methylethyl)-2-oxo-5-pyrimidinecarboxylic acid methyl esters. The present invention can not only solve the environmental pollution problems and safety risk problems present in existing preparation methods, but also can prepare a target product in high yield.

The invention belongs to the field of pharmaceutical chemical engineering, and particularly relates to a crystal form of a rosuvastatin calcium intermediate and a preparation method thereof, the rosuvastatin calcium intermediate is (4R-CIS)-6-chloromethyl-2, 2-dimethyl-1, 3-dioxolane-4-tert-butyl acetate, and a synthetic route of the rosuvastatin calcium intermediate comprises the following steps: (1) taking a compound II, adding 2, 2-dimethoxypropane and p-toluenesulfonic acid, and stirring to obtain a compound II; performing stirring reaction under nitrogen protection; (2) adding saturated sodium bicarbonate to adjust pH, adding ethyl acetate for liquid separation, extracting a water phase with ethyl acetate, combining organic phases, washing with water, washing with saturated sodium chloride, drying with anhydrous sodium sulfate, carrying out suction filtration and spin-drying, then adding n-heptane, heating until reflux dissolution is clarified, cooling for crystallization, carrying out suction filtration and drying to obtain a compound I; the crystal form of the rosuvastatin calcium intermediate is simple in preparation process, high in purity and good in chemical stability, can be better suitable for preparation of pharmaceutical preparations and large-scale production, and has wide application prospects.

This invention discloses a compound tablet containing sacubitril / valsartan and rosuvastatin calcium, and its preparation method, belonging to the field of pharmaceutical preparation technology. The technical solution comprises: an active ingredient and pharmaceutical excipients; the active ingredient includes sacubitril / valsartan sodium and rosuvastatin calcium; the pharmaceutical excipients include fillers, binders, disintegrants, stabilizers, glidants, lubricants, and a gastrointestinal film-coating premix; the tablets are prepared using a dry granulation process. This invention solves the problems of poor adherence to single-drug use, asynchronous dissolution, and insufficient stability, achieving a synergistic effect of lowering blood pressure and lipids. Furthermore, the preparation process is simple, efficient, and suitable for industrial production.

The disclosed embodiment relates to a palatable icosapent ethyl formulation with statin. More particularly, the formulation comprises of icosapent ethyl, antioxidant, statin, alkalizer, wetting agent, suspending agent, diluent, flavouring agent, and sweetening agent. Furthermore, the statin is rosuvastatin calcium; the antioxidant is tocopherol; the alkalizer is magnesium oxide; the wetting agent is docusate sodium; the suspending agent is colloidal silicon dioxide; the diluent is miglyol 812; the flavouring agent is peppermint oil; and the sweetening agent is sucralose. The said formulation is an oral suspension for reduction of triglyceride (TG) levels and stabilization of atherosclerotic plaque.

The invention provides a method for refining rosuvastatin calcium, which comprises the following steps of: dissolving a rosuvastatin calcium crude product by using dichloromethane, filtering, adding purified water into filtrate, filtering, collecting a filter cake, and drying and crushing the filter cake to obtain amorphous rosuvastatin calcium powder. According to the refining method, amorphous rosuvastatin calcium with high purity, low chloride content and solubility meeting the standard can be directly prepared, and the refining method is easy to operate, high in product quality, high in yield and suitable for industrial production.

The invention provides a method for detecting and analyzing a 1-phenyl-5-tetrazole-thione impurity in a rosuvastatin calcium side chain, which comprises the following steps: detecting a blank solution, a reference solution and a test solution by adopting high performance liquid chromatography to obtain a chromatogram, and confirming the content of 1-phenyl-5-tetrazole-thione according to the chromatogram. According to the method for detecting and analyzing the impurities of the 1-phenyl-5-tetrazole-thione, the impurities are well separated from adjacent peaks, the applicability is high, the accuracy is good, the specificity is high, the reproducibility and durability are good, the quantitation limit is 5.0040 mu g / mL, and the detection limit is 2.5020 mu g / mL. According to the method, the technical blank of 1-phenyl-5-tetrazole-thione trace impurity detection in the side chain of the rosuvastatin calcium is filled, the purity and the stability of the rosuvastatin calcium product can be better improved, safety guarantee is provided for strict control of the medicine quality, and the method has good application prospects and application values.

The utility model discloses a liquid preparation device for rosuvastatin calcium production, which comprises a liquid preparation box, a stirring mechanism is arranged in the liquid preparation box, a gravity sensing bin, a quantitative liquid discharge bin and a control box are arranged on the liquid preparation box, a supporting column is arranged in the gravity sensing bin, a weighing plate is arranged on the supporting column, and a liquid outlet is formed in the weighing plate. The weighing plate is provided with a feeding pipe, a gravity sensor is arranged between the weighing plate and the supporting column, the gravity sensor is electrically connected with the control box, a liquid guide pipe is arranged at the bottom of the quantitative liquid discharging bin, electric valves are arranged in the feeding pipe and the liquid guide pipe, and the electric valves are electrically connected with the control box. According to the utility model, the amount of powdery raw materials for rosuvastatin calcium production can be determined through the gravity sensing bin, so that the amount of liquid raw materials required by liquid preparation can be controlled by controlling the electrically operated valve on the liquid guide pipe and the scale marks on the observation window through the control box, the waste of the liquid raw materials is reduced, and resources are saved.

The invention relates to the technical field of organic synthesis, in particular to a preparation method of a rosuvastatin calcium intermediate. The method comprises the following steps: uniformly mixing reactants, a photocatalyst and a first organic solvent to form a reaction system; the reaction system is subjected to a catalytic reaction under the visible light irradiation condition and the air environment, and a target product is prepared. The molar weight of the photocatalyst is 5%-15% of the molar weight of the reactants; 6-(4-fluorophenyl)-1, 2-dihydro-4-(1-methyl ethyl)-2-oxo-5-tetrahydropyrimidinecarboxylic acid methyl ester is used as a reactant; the photocatalyst is a dye photocatalyst; the target product is 6-(4-fluorophenyl)-1, 2-dihydro-4-(1-methyl ethyl)-2-oxo-5-pyrimidinecarboxylic acid methyl ester. The method not only can solve the problems of environmental pollution and safety risk in the existing preparation method, but also can prepare a high-yield target product.

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining chiral isomers in rosuvastatin calcium ezetimibe tablets. The invention provides a method for determining a chiral isomer in a rosuvastatin calcium ezetimibe tablet, which comprises the following steps: changing an isocratic elution mode into a gradient elution mode, establishing an effective pretreatment method, optimizing a test solution solvent and a high performance liquid chromatography with specific parameters, and determining the chiral isomer in the rosuvastatin calcium ezetimibe tablet. The problems that the solubility difference of rosuvastatin calcium and ezetimibe is large, rosuvastatin calcium is unstable to acid, ezetimibe is unstable to alkali, isocratic elution time is too long and the like are solved. The quality of chiral isomers of rosuvastatin calcium and ezetimibe, which are recorded in European Pharmacopoeia and United States Pharmacopoeia, is controlled; establishing sensitivity and system applicability requirements; the retention time and correction factors of specific impurities are marked, so that the detection result is more accurate.

The invention provides a rosuvastatin calcium oral instant film preparation. The rosuvastatin calcium oral instant film preparation comprises rosuvastatin calcium, a stabilizer, a high-water-solubility film-forming material and pharmaceutically acceptable auxiliary materials. The rosuvastatin calcium oral instant film preparation has good stability, the dissolution rate of the rosuvastatin calcium oral instant film preparation in a hydrochloric acid medium with the pH value of 1.0 within 15 min is larger than 85%, and the dissolution curve of the rosuvastatin calcium oral instant film preparation is close to that of commercially available rosuvastatin calcium oral disintegrating tablets. The invention also provides a preparation method of the rosuvastatin calcium oral instant film preparation, which comprises the following steps: (1) mixing rosuvastatin calcium with the stabilizer, and carrying out micronization treatment to obtain a mixture 1; (2) dispersing a high-water-solubility film-forming material into purified water, and dissolving to obtain a film-forming solution; and (3) adding the mixture in the step (1) into the film forming liquid, and uniformly mixing to obtain a mixture 2.

This invention relates to the field of pharmaceutical analysis technology and discloses a method for detecting the content of ezetimibe and rosuvastatin calcium tablets using a reversed-phase chromatography system. The method employs high-performance liquid chromatography (HPLC) with 0.1% trifluoroacetic acid solution as mobile phase A, acetonitrile as mobile phase B, and methanol as mobile phase C. Gradient elution is performed using an octadecylsilane-bonded silica column. The detection wavelength is 242 nm, and the injection volume is 10 μL. The content of ezetimibe and rosuvastatin calcium is calculated using the external standard method. This method can effectively separate the two main components from various degradation impurities, exhibiting good peak shape and excellent resolution. It meets the requirements for pharmaceutical quality control in terms of specificity, limit of quantitation, limit of detection, linear range, precision, accuracy, repeatability, and robustness. The system is stable and provides a reliable technical solution for the quality detection of ezetimibe and rosuvastatin calcium tablets.