Sudesh D. Shambharkar*, P. D. Hamrapurkar, Abhijeet Parate, and Supriya Vijayaraghavan Department of Pharmaceutical Analysis, Prin K. M. Kundnani College of Pharmacy, Jote Joy Building, Rambhau Salgaokar Marg, Cuffe Parade, Colaba, Mumbai, India
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Stability is considered one of the most important criteria in pharmaceutical quality control. With this objective a stability indicating high performance liquid chromatographic method has been established for analysis of Pazufloxacin mesylate in the presence of degradation products. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis, thermal degradation. Extensive degradation was found in Oxidative medium. Minimum degradation was found in acid degradation while there was no degradation found in Basic, thermal and photolytic condition. Successful separation of a drug from degradation product formed under stress condition was achieved on C18 column using methanol and 50mM Potassium dihydrogen Orthophosphate (40:60, v/v), pH4.5 adjusted with Acetic acid as a mobile phase. Flow rate was 1ml min-1 and the detector was set at wavelength of 249nm. The method was validated for linearity, range, precision, and accuracy, limit of quantification and limit of detection. Because method effectively separates the drug from their degradation products, it can be used as stability indicating method.ABSTRACT
Keywords:
Pazufloxacin mesylate; stress degradation; stability indicating method; RP-HPLC.
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ARTICLE INFORMATION
Received:
2012-06-30
Revised:
2013-06-08
Accepted:
2013-07-31
Available Online:
2013-12-01
Shambharkar, S.D., Hamrapurkar, P.D., Parate, A., Vijayaraghavan, S. 2013. Optimization and validation of RP-HPLC stability indicating method for determination of pazufloxacin mesylate and its degraded product. International Journal of Applied Science and Engineering, 11, 423–432. https://doi.org/10.6703/IJASE.2013.11(4).423
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