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Content detecting and control method of epalrestat tablets

A technology for epalrestat tablets and detection and control, which is applied in the field of quality control of epalrestat tablets to achieve the effects of high detection sensitivity, maintenance of interests and good separation effect

Active Publication Date: 2013-04-24
YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Epalrestat tablets in the prior art do not have accurate and reliable, high sensitivity, good detection method for stability

Method used

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  • Content detecting and control method of epalrestat tablets
  • Content detecting and control method of epalrestat tablets
  • Content detecting and control method of epalrestat tablets

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Embodiment Construction

[0023] The present invention is further illustrated below in conjunction with specific embodiments, should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention, after having read the present invention, those skilled in the art will understand the various equivalent forms of the present invention All modifications fall within the scope defined by the appended claims of this application.

[0024] Methodological investigation of the content detection and control method of Epalrestat Tablets in Example 1

[0025] 1.1 Stability experiment

[0026] Take an appropriate amount of epalrestat tablet sample, accurately weigh 20mg of epalrestat reference substance, add 8mL N,N-dimethylformamide and 2mL internal standard solution respectively, shake and mix, and then take 2mL of the solution for N ,N-dimethylformamide to 20mL, that is, the standard solution, for later use; internal standard ...

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Abstract

The invention discloses a content detecting and control method of epalrestat tablets, according to the method, high-performance liquid chromatography is used for detecting the epalrestat tablets. Analytical conditions such as an optimal internal standard compound, mobile phase composition, an elution program, elution flow velocity, a detecting wavelength and a chromatographic column are optimized through a large number of experiments. Many times of experimental verification indicates that the content detecting and control method of the epalrestat tablets is good in stability and repeatability, high in analysis efficiency, good in resolution and capable of detecting epalrestat sensitively and accurately in a qualitative and quantitative mode, so that the quality of the epalrestat tablets can be evaluated objectively, comprehensively and accurately, and the content detecting and control method of the epalrestat tablets is of great significance in controlling of the quality of the epalrestat tablets and ensuring of clinical effects.

Description

technical field [0001] The invention relates to a quality control method of pharmaceutical preparations, in particular to a quality control method of epalrestat tablets. Background technique [0002] Epalrestat tablets produced by Nanjing Hailing Pharmaceutical Co., Ltd. of Yangzijiang Pharmaceutical Group are widely used clinically for diabetic neuropathy. Epalrestat tablets in the prior art have no accurate, reliable, high-sensitivity, and good-stability detection methods. Therefore, in order to control the clinical safety of epalrestat tablet preparations and safeguard the interests of patients, it is necessary to research and design a method that can accurately detect the active ingredient epalrestat in epalrestat tablet preparations based on the existing technology. Method for detection of slices. Contents of the invention [0003] Purpose of the invention: the purpose of the present invention is to solve the deficiencies in the prior art, to provide a good separati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 陶元景王丽楠
Owner YANGTZE RIVER PHARM GRP NANJING HAILING PHARM CO LTD
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