Method for detecting polymer impurities in cefadroxil raw material medicine and preparation of cefadroxil raw material medicine

A technique for detecting cefadroxil and its detection method, which is applied in the field of detection of polymer impurities in cefadroxil bulk drug and its preparations, can solve problems such as poor method specificity and small molecule impurity interference, and achieve good separation, good durability, good effect of specificity

CN113607870APending Publication Date: 2021-11-05NAT INST FOR FOOD & DRUG CONTROL
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
Publication Date
2021-11-05

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Abstract

The invention provides a method for detecting polymer impurities in a cefadroxil bulk drug or a preparation thereof, which is based on reversed-phase high-performance liquid chromatography. The method comprises the following steps that chromatographic conditions are established, and a polymer impurity positioning control solution is prepared, wherein the chromatographic conditions are as follows, a stationary phase is octadecyl silane bonded silica gel, a mobile phase is 0.02 mol/L monopotassium phosphate solution with the pH value of 4.8-5.2 as a mobile phase A, methanol is taken as a mobile phase B, and gradient elution is performed; the flow rate is 0.9 to 1.1 ml/min; the column temperature is 28-32 DEG C; the detection wavelength is 220nm. According to the method for detecting the polymer impurities in the cefadroxil bulk drug or the preparation of the cefadroxil bulk drug, multiple polymer impurities can be detected at the same time, the separation degree of all the polymer impurities is good, and the method can eliminate interference of small molecule impurities in the cefadroxil bulk drug or the preparation of the cefadroxil bulk drug.
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