Detection method of amoxicillin and clavulanate potassium tablets
A technology of amoxicillin-clavulanate potassium and amoxicillin is applied in the field of drug analysis and can solve the problems of peak tailing, poor resolution, unsatisfactory detection limit and high limit of quantification, etc.
Pending Publication Date: 2022-07-01
LUNAN PHARMA GROUP CORPORATION
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Problems solved by technology
[0006] The above methods all measure the content of the compound preparation of amoxicillin and potassium clavulanate. However, in repeated experiments, it is found that although the main peak and the impurity peak can be basically separated in the method, there is peak tailing and poor resolution. , detection limit and quantitative limit can not meet the micro analysis and other problems
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Embodiment 1
[0100] Instrument and conditions: Waters liquid chromatography system, 2998 detector, Agilent C18 column (4.6×250mm, 5μm); 0.05mol / L sodium dihydrogen phosphate (pH4.4)-methanol (95:5) as Mobile phase, isocratic elution, column temperature 25°C, flow rate 1.0ml / min, injection volume 20μl; detection wavelength gradient conditions are as follows:
[0101]
[0102] experiment:
[0103] 1. Take an appropriate amount of the reference substance, prepare a reference substance solution containing 0.25mg / ml of clavulanic acid and 0.5mg / ml of amoxicillin with water, accurately measure 20μl and inject it into the liquid chromatograph, record the chromatogram, see the attached HPLC spectrum figure 2 .
[0104] Depend on figure 2 It can be seen that the retention time of amoxicillin is about 6.059min, the retention time of clavulanic acid is about 3.356min, and there is no impurity peak that interferes with content detection.
[0105] Linearity and range: take an appropriate amount...
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Abstract
The invention relates to a method for detecting the contents of amoxicillin and clavulanic acid in amoxicillin and clavulanic acid potassium tablets, which is characterized in that high performance liquid chromatography is used for detection, a stationary phase is a chromatographic column with octadecyl bonded silica gel as a filler, water is used as a solvent, 0.05 mol / L sodium dihydrogen phosphate (pH 4.4)-methanol (95: 5) is used as a mobile phase, isocratic elution is performed, and the detection wavelength is gradient. The detection method can effectively detect the contents of amoxicillin and clavulanic acid, has the advantages of high sensitivity, high degree of separation, good repeatability and durability, simple operation and stable and reliable result, can be used for controlling the contents of amoxicillin and clavulanic acid in the amoxicillin and clavulanic acid potassium tablet, and has wide application prospects. And an effective guarantee is provided for the quality of final finished products.
Description
technical field [0001] The invention relates to a method for detecting amoxicillin and clavulanate potassium tablets, in particular to a method for detecting amoxicillin and clavulanate contents in amoxicillin and clavulanate potassium tablets raw materials and preparations by high performance liquid chromatography The method belongs to the field of drug analysis. Background technique [0002] This product is a compound preparation of amoxicillin and potassium clavulanate. Amoxicillin is a broad-spectrum penicillin antibiotic. Clavulanate potassium itself has only weak antibacterial activity, but has a strong broad-spectrum beta-lactamase inhibitory effect. The combination of the two can protect amoxicillin from beta-lactamase hydrolysis. The antibacterial spectrum of this product is the same as that of amoxicillin, and it has been expanded. It is widely used in the treatment of various infectious diseases clinically. [0003] At present, the content determination method ...
Claims
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Login to View More IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 杜娟刘阿利
Owner LUNAN PHARMA GROUP CORPORATION