Updates and amendments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020
Objective:To propose updates and amendments for the nitroglycerin tablets quality in the Chinese phar-macopoeia 2020 due to the failure of effective separation of 4 known impurities and nonseparation of free nitrate ion and excipients.Methods:Related substances were analyzed using gradient elution by HPLC,and free nitrate ion was determined on SAX column by different HPLC method.Results:Using the improved method to test the related substances and free nitrate ion of nitroglycerin tablets,the content of the maximum individual impurity were not more than 0.5％,the total content was not more than 2.4％and the content of free nitrate ion was not more than 6.3％.Conclusion:The improved method is accurate and feasible.It provided a reference for the updates and amend-ments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020.
nitroglycerinHPLCfree nitrate ionrelated substanceupdates and amendments of quality standard
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