Detection method and content determining method of sodium calcium edetate in pantoprazole sodium for injecting

A technology of calcium sodium edetate and pantoprazole sodium, which is applied to measuring devices, instruments, scientific instruments, etc., and can solve problems such as interference in measurement results and low specificity

Active Publication Date: 2012-11-28
CHENGDU BAIYU JINGELAI PHARMA CO LTD
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Problems solved by technology

When using the above titration method to measure the content of ediben calcium sodium in pantoprazole sodium for injection, th

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  • Detection method and content determining method of sodium calcium edetate in pantoprazole sodium for injecting
  • Detection method and content determining method of sodium calcium edetate in pantoprazole sodium for injecting
  • Detection method and content determining method of sodium calcium edetate in pantoprazole sodium for injecting

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Embodiment Construction

[0038] The following describes but does not limit the present invention through the description of specific embodiments of the present invention.

[0039] At present, the related technology for detecting calcium sodium edetate in the excipient of pantoprazole sodium for injection includes the method of titration to determine the content of calcium sodium edetate in the Pharmacopoeia of the People’s Republic of China (hereinafter referred to as the Chinese Pharmacopoeia). The regulations are as follows:

[0040] Take about 50mg of pantoprazole sodium for injection, accurately weigh it, place it in an Erlenmeyer flask, add 100ml of water to dissolve, add 3 drops of xylenol orange indicator solution, and titrate with bismuth nitrate titrant (0.01mol / L) to the solution Change from yellow to red. Each 1ml of bismuth nitrate titrant (0.01mol / L) is equivalent to 3.743mg of C 10 H 12 CaN 2 Na 2 O 8 . However, this method has the defect that the main component, pantoprazole sodium, interf...

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Abstract

The invention belongs to the field of medicament analysis and particularly relates to a detection method and a content determining method for sodium calcium edetate as an accessory in pantoprazole sodium for injecting. The invention aims at solving the technical problem of providing a method with the advantages of simpleness in and convenience for operation, quickness and accuracy for detecting the sodium calcium edetate as the accessory in the pantoprazole sodium for injecting. HPLC (High Performance Liquid Chromatography) detection conditions are as follows: a stationary phase: octadecylsilane bonded silica gel is used as a filling agent; a mobile phase: in terms of volume, an ion pair buffer solution is 85-95 percent, acetonitrile is 5-15 percent and the pH value is adjusted to 2.2-2.6 with phosphoric acid; the flowing speed is 0.8-1.2 ml/min; the column temperature is 30-40DEG C; the detection wavelength is 250-260 nm; and the theoretical plate number is required not to be lower than 2000 calculated in terms of a sodium calcium edetate peak. The detection method has the advantages of simple and convenient operation, accurate and reliable determination result, stronger specificity and shorter detection time; and the retention time of a main peak is about 6 minutes.

Description

Technical field [0001] The invention belongs to the field of drug analysis, and specifically relates to a detection method and a content determination method of the auxiliary material calcium sodium edetate in pantoprazole sodium for injection. Background technique [0002] Pantoprazole sodium for injection is mainly used for acute upper gastrointestinal bleeding caused by duodenal ulcer, gastric ulcer, acute gastric mucosal disease, compound gastric ulcer, etc. This product has a low affinity with liver cytochrome P450. It also has a phase II metabolic pathway, so it has less interaction with other drugs metabolized by cytochrome P450 enzymes than omeprazole and lansoprazole. In addition, pantoprazole sodium is susceptible to the catalytic hydrolysis of metal ions, which affects the stability of the product during preparation and instillation. Therefore, it is necessary to add a metal ion complexing agent, and disodium edetate is added to all commercially available samples. How...

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Application Information

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IPC IPC(8): G01N30/02G01N30/36
Inventor 孙毅田阿娟宋务雄
Owner CHENGDU BAIYU JINGELAI PHARMA CO LTD
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