DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR THE DETERMINATION OF METRONIDAZOLE BENZOATE AND RELATED IMPURITES IN BULK AND PHARMACEUTICAL FORMULATIONSAbstract
A simple, selective, precise and reliable HPLC method of analysis has been developed and validated for determination of the metronidazole benzoate and related impurities, including metronidazole, 2-methyl-5-nitromidazole and benzoic acidin bulk and marketed formulations. The method employed CN-RP column as stationary phase and acetonitrile and 0.1% octansulfonic acid sodium salt as mobile phase. The method was validated in terms of linearity, precision and accuracy. The LOD and LOQ were 0.076, 0.031, 0.033 and 0.024 μg/ml and 0.232, 0.095, 0.098 and 0.073 μg/ml respectively for metronidazole benzoate, metronidazole, 2-methyl-5-nitromidazole and benzoic acid. The average percentage recovery of metronidazole benzoate and related impurities was found to be within 98.6 – 101.5 % of range. The developed method can be successfully used for identification and quantification of metronidazole benzoate and related impurities in bulk and formulations.
Levon A. Melikyan, Simak S. Martirosyan, Rosa S. Grigoryan, Hakob V. Topchyan and Tigran K. Davtyan*
Scientific Center of Drug and Medical Technology Expertise JSC Ministry of Health of Armenia, Komitas 49/4, Yerevan 0051, Republic of Armenia
01 March, 2013
21 May, 2013
29 June, 2013
01 July, 2013