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Content measuring method of metformin hydrochloride enteric coated tablet

A metformin hydrochloride enteric and metformin hydrochloride technology, which is applied in the field of content determination of metformin hydrochloride enteric-coated tablets, can solve the problems of inaccurate ultraviolet spectrophotometry, inaccurate metformin hydrochloride enteric-coated tablets, etc., and achieves the improvement of accuracy and sensitivity. Effect

Inactive Publication Date: 2010-07-14
贵州天安药业股份有限公司
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AI Technical Summary

Problems solved by technology

[0014] The method for content determination in the existing quality standards of Metformin Hydrochloride Enteric-coated Tablets is to use ultraviolet spectrophotometry, but for the content determination of Metformin Hydrochloride Enteric-coated Tablets, UV spectrophotometry is not accurate enough
[0015] The applicant once disclosed the patent of CN101339178A, which adopted the HPLC method to control the quality of dimethyl enteric-coated tablets. The release amount in gastric juice has improved the release amount of dimethyl hydrochloride enteric-coated tablets in simulated intestinal juice. Although it has adopted the HPLC method to effectively control the related substances, the release amount of dimethyl hydrochloride enteric-coated tablets is measured under the corresponding chromatographic conditions. content is not accurate

Method used

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  • Content measuring method of metformin hydrochloride enteric coated tablet
  • Content measuring method of metformin hydrochloride enteric coated tablet
  • Content measuring method of metformin hydrochloride enteric coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Chromatographic conditions and system suitability test: use sulfonic acid group cation exchange bonded silica gel as filler, phosphoric acid-1.7% ammonium dihydrogen phosphate solution at pH 3.0:methanol=70:30 (volume ratio) as mobile phase, detect The wavelength is 233nm, and the number of theoretical plates is not less than 3000 based on the metformin hydrochloride peak;

[0065] Preparation of reference substance solution: Take 20 mg of metformin hydrochloride reference substance, accurately weighed, put in a 100ml measuring bottle, add an appropriate amount of mobile phase, sonicate to dissolve metformin hydrochloride and dilute to the mark with mobile phase, shake well, accurately measure 1ml, place In a 10ml measuring bottle, add mobile phase to the mark, shake well, and get it;

[0066] The preparation of need testing solution: get 10 metformin hydrochloride enteric-coated tablets, grind finely, accurately weigh the appropriate amount of medicine powder (equivale...

Embodiment 2

[0069] Chromatographic conditions and system suitability test: use sulfonic acid group cation exchange bonded silica gel as filler, phosphoric acid-1.7% sodium dihydrogen phosphate solution at pH 2.0: methanol = 90: 10 (volume ratio) as mobile phase, detect The wavelength is 233nm, and the number of theoretical plates is not less than 3000 based on the metformin hydrochloride peak;

[0070] Then measure according to the method of embodiment 1.

Embodiment 3

[0072] Chromatographic conditions and system suitability test: use sulfonic acid group cation exchange bonded silica gel as filler, phosphoric acid-1.7% potassium dihydrogen phosphate solution at pH 4.0:methanol=40:60 (volume ratio) as mobile phase, detect The wavelength is 233nm, and the number of theoretical plates is not less than 3000 based on the metformin hydrochloride peak;

[0073] Then measure according to the method of embodiment 1.

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Abstract

The invention provides a content measuring method of a metformin hydrochloride enteric coated tablet, which comprises the following steps: using metformin hydrochloride as a reference substance and measuring the content of the metformin hydrochloride in the enteric coated tablet by using a high performance liquid chromatography. Compared with the prior art, the invention uses the high performance liquid chromatography to measure the content of the metformin hydrochloride enteric coated tablet, improves the accuracy compared with the prior ultraviolet spectrophotometric method, and provides better standards for the quality control of the metformin hydrochloride enteric coated tablet.

Description

technical field [0001] The invention relates to metformin hydrochloride enteric-coated tablets, in particular to a method for determining the content of metformin hydrochloride enteric-coated tablets. Background technique [0002] Metformin hydrochloride enteric-coated tablets are hypoglycemic drugs, which can reduce the fasting and postprandial hyperglycemia symptoms of patients with type II diabetes, and HbAlc can be reduced by 1% to 2%. It is used for patients with type II diabetes who are not satisfied with simple diet control, especially obesity And those with hyperinsulinemia, using this drug not only has the effect of lowering blood sugar, but also has the effect of reducing weight and hyperinsulinemia. It can be effective for some patients with poor curative effect of sulfonylureas, such as combined with sulfonylurea hypoglycemic agents, small intestinal glycosidase inhibitors or thiazolidinedione hypoglycemic agents, the effect is better than that of each alone. It...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/50G01N30/06
Inventor 张凡方洪海尚丽江金联荪
Owner 贵州天安药业股份有限公司
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