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
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[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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