Method for detecting potential mutagenic impurities in pitavastatin calcium tablets

A technique for detecting pitavastatin calcium and its detection method, which is applied in the field of drug quality detection, can solve the problems of being unable to detect the content of impurity 1 and impurity 2, interfering with the detection of impurity 1 and impurity 2, etc., and achieve improved drug safety, good specificity, Simple operation effect

Inactive Publication Date: 2020-08-07
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

After testing, the detection method for related substances contained in JP17 pitavastatin calcium tablets can separate and detect various impurities, but cannot detect the content of impurity 1 and impurity 2. During the detection process, the characteristic peaks of impurity 1 and impurity 2 are different from those of other Cannot be separated, interfere with the detection of impurity 1 and impurity 2

Method used

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  • Method for detecting potential mutagenic impurities in pitavastatin calcium tablets
  • Method for detecting potential mutagenic impurities in pitavastatin calcium tablets
  • Method for detecting potential mutagenic impurities in pitavastatin calcium tablets

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preparation example Construction

[0043] The preparation method of mobile phase A is as follows: weigh 0.6 g of acetic acid, dilute to 1 L with deionized water, and adjust the pH value to 3.5 with sodium acetate solution.

[0044] It has been proved by experiments that the organic filter membrane has an adsorption effect on the impurity 2, which will lead to a decrease in the chromatographic peak area. Therefore, centrifugation or standing should be used for sample treatment, and filter membrane filtration should not be used.

[0045] Preparation of impurity reference substance solution: Weigh 5.0mg each of impurity 1 and impurity 2, put in a 100mL measuring bottle, add solvent to dissolve and dilute to the mark, shake well, and use it as impurity reference substance mother liquor; take impurity reference substance mother liquor 3mL, put in 100mL volume bottle, dilute to the mark with a solvent, shake well, and use it as the stock solution of the impurity reference substance; take 2 mL of the stock solution of ...

Embodiment 1

[0050] Good specificity:

[0051] It has been verified that (1) the solvent and blank excipients do not interfere with the detection of the main peak of pitavastatin calcium, impurity 1 peak, and impurity 2 peak; (2) the separation between the main peak and adjacent impurities and between adjacent impurities is not less than 1.5; (3) system suitability The retention time and resolution of each peak in the solution are shown in Table 2.

[0052] Table 2 System Suitability Solution Test Results

[0053]

Embodiment 2

[0055] Good system suitability:

[0056] The solvent does not interfere with the detection of each peak, the number of theoretical plates for the main peak is 15977; the number of theoretical plates for impurity 1 is 45800, and the tailing factor is 1.19; The RSDs of the peak areas of impurity 2 were all less than 1%. The results showed good systematicness.

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Abstract

The invention relates to the field of medicine quality detection, in particular to a method for detecting potential mutagenic impurities in pitavastatin calcium tablets. The method comprises the following steps: dissolving a to-be-detected sample by adopting a solvent, and detecting by adopting a high performance liquid chromatography under the chromatographic conditions that a mobile phase comprises an organic acid salt buffer solution and acetonitrile; the flow rate is 1.0 mL / min; the column temperature is 25-40 DEG C; a chromatographic column: octadecylsilane chemically bonded silica is used as a filler; the sample injection volume is 50 [mu] L; the detection wavelength ranges from 270 nm to 280 nm; an elution mode is gradient elution; the potential mutagenic impurities are an impurity1 and an impurity 2. According to the method disclosed by the invention, the pitavastatin calcium, the impurity 1 and the impurity 2 can be effectively separated; meanwhile, interference of other related impurities of pitavastatin calcium on detection of the impurity 1 and the impurity 2 is avoided, the content of potential mutagenic impurities 1 and 2 of the pitavastatin calcium tablets can be accurately detected, the quality of the pitavastatin calcium tablets is effectively monitored, and the medication safety is improved.

Description

technical field [0001] The invention relates to the field of drug quality detection, in particular to a detection method for potential mutagenic impurities in pitavastatin calcium tablets. Background technique [0002] Statins, as HMG-CoA reductase inhibitors, are widely used to lower blood lipids and cholesterol, and pitavastatin is known as a "super statin". Pitavastatin calcium tablets are the latest generation of drugs for the treatment of hypercholesterolemia in the world today , compared with similar products, it has the advantages of small dosage, few side effects and definite curative effect. According to reports, pitavastatin calcium has the effect of significantly lowering low-density lipoprotein cholesterol, and the effect is stronger than that of several other statins. The drug is effective for adolescent patients and has extensive clinical value. [0003] Pitavastatin calcium is easily degraded after being irradiated by light, resulting in a variety of impuriti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675G01N2030/047
Inventor 王朋马莹莹胡中花李梦琪李颖张晓谢建卫周玲玲李晶玉王君杰王波
Owner SHANDONG QIDU PHARMA
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