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PudxPA D. PAaPbAarTar a, P. D. AaPrapurTar a, AbAijxxt Paratx a and Pupriya VijayaragAavan a
aDxpartPxnt of PAarPaZxutiZal AnalyPiP, Prin T. P. Tundnani Zollxgx of PAarPaZy, Jotx Joy Building, RaPbAau PalgaoTar Parg, Zuffx Paradx, Zolaba, PuPbai, India
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Abstract:
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.
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Keywords: Pazufloxacin mesylate; stress degradation; stability indicating method; RP-HPLC.
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*Corresponding author; e-mail: sudeshshambharkar@gmail.com
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©
2013
CSME , ISSN 0257-9731
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