Method for determining D-captopril and captopril-related substances 8 in captopril tablets by adopting high performance liquid chromatography

Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly relates to a method for determining D-captopril and captopril related substances 8 in captopril tablets by adopting high performance liquid chromatography. The method comprises the steps that a test solution containing captopril is detected through adoption of high performance liquid chromatography, captopril, D-captopril and captopril related substances 8 are obtained, wherein the conditions of high performance liquid chromatography detection are as follows: a chromatographic column is an amylose-tri(3,5-xylylcarbamate) coating type chiral chromatographic column, the mobile phase is a mixed solution of n-hexane, isopropanol, methanol and trifluoroacetic acid, the elution mode is isocratic elution. According to the invention, the contents of D-captopril and captopril-related substances 8 in the captopril tablets can be quantitatively determined, so that the quality of the captopril tablets is effectively controlled.

Description

Technical field [0001] The invention belongs to the technical field of drug analysis, and specifically relates to a method for determining D-captopril and captopril related substances 8 in captopril tablets by high performance liquid chromatography. Background technique [0002] Captopril is the first discovered angiotensin converting enzyme inhibitor (ACEI), a synthetic non-peptide compound. Since its appearance in the 1990s, it has shifted from a special drug for the treatment of hypertension and congestive heart failure. Clinical medications for the treatment of other cardiovascular diseases, rheumatoid arthritis, pulmonary hypertension and other diseases have great clinical value. Captopril is also known as (S)-1-(3-mercapto-2-methyl-1-oxopropyl)-L-proline, and its structural formula is shown in the following formula I. [0003] [0004] There are many related substances in captopril in the process of preparation and storage. Only captopril disulfide impurities are specified ...

AI Technical Summary

Problems solved by technology

[0014] In the process of research and development of generic captopril tablets, it is necessary to conduct research on D-captopril and captopril related substance 8 of captopril tablets. During the test, it is found that the related substances adopting the European Pharmacopoeia raw material standards When the method was used to determine D-captopril and captopril related substance 8 in captopril tablets, the peak time was consistent with that of captopril and could not be effectively separated from captopril; the impurity F The method is to use the pre-column derivatization and the area normalization method of gas chromatography to determine the content. This method has the problems of cumbersome operation, unstable measurement results and poor repeatability.

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