Determination method of main drug content in omeprazole solid preparation

Abstract

The invention provides a determination method of a main drug content in an omeprazole solid preparation. A mixed solvent of sodium heptanesulfonate and acetonitrile is used as a mobile phase, methyl alcohol is used as a diluent, and high performance liquid chromatography (HPLC) is adopted for detecting. The determination method provided by the invention is subjected to methodology validation, andthe determination method of the main drug content in the omeprazole solid preparation provided by the invention has a great advantage on sample detection compared with a determination method of an existing detection technology on the content in the omeprazole solid preparation, so that the retention time of omeprazole can be stable, the separation degree is favorable, and the number of theoreticalplates can reach to 10000 or more; the solubleness of the omeprazole by methyl alcohol is favorable, and the problem of caking is solved; meanwhile, the error of manual operation is reduced, and thedetection accuracy is improved.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, in particular to a method for determining the content of the main drug in omeprazole solid preparations. Background technique [0002] Peptic ulcer is a common and frequently-occurring disease, and about 5% to 6% of people in the world have suffered from it. 80sH + -K + -The advent of ATPase (proton pump) inhibitors has made a breakthrough in the treatment of peptic ulcer and has become the strongest new acid-suppressing drug. Proton pump inhibitors such as omeprazole have opened up a new way of action in the treatment of peptic ulcer, making the treatment of peptic ulcer no longer a difficult problem. Omeprazole is a benzimidazole proton pump inhibitor, which can inhibit the intramembrane proton pump (H + -K + -ATPase system), so that the H in the cell wall + It cannot be transported into the gastric juice, thus exerting the effect of inhibiting the secretion of gastric...

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Problems solved by technology

But this detection method mainly has the following defects: 1) the mobile phase configuration of this detection method uses a large amount of phosphate, and phosphate easily blocks the chromatographic column, and is difficult to clean, causes chromatographic column to clog, makes chromatographic column loss serious, produces Chromatographic column pressure rises sharply, retention time drifts, baseline instability and other problems affect the detection of omeprazole raw materials and preparations; 2) and in this method, what diluent used is phosphate solution (pH11.0), the The diluent is easy to make the content of omeprazole enteric-coated capsules sticky, difficult to dissolve, and it is easy to cause human error in the analysis process

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