Journal :   Asian Journal of Research in Chemistry

Volume No. :   3

Issue No. :  3

Year :  2010

Pages :   600-603

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Stability indicating Fast LC method for the estimation of impurities of Pantoprazole in Tablet Dosage Forms



Address:   Paluru Rudra Mohan Reddy1*, J Sreeramulu1, Petla Y. Naidu2 and A. Rajasekhara Reddy2
1 Department of Chemistry, S.K. University, Anantapur 515003, India
2Orchid Chemicals and Pharmaceuticals Ltd, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram District, Tamilnadu 602105, India
*Corresponding Author
DOI No:

ABSTRACT:
A fast, stability-indicating reversed phase liquid chromatographic method has been developed and subsequently validated for the estimation of impurities of Pantoprazole. The developed method utilizes sub 2-µm C-18 column and mobile phase consisting of ammonium acetate buffer – acetonitrile with gradient elution, at a flow rate of 0.8 mL per minute. The detection was carried out at 290 nm. The method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification, ruggedness and robustness. This method has been successfully applied to pharmaceutical formulation and no interference from the tablet excipients was found. As the proposed method could effectively separate the drug from its degradants / impurities, ie, pantoprazole related compound A (PA), pantoprazole related compound B (PB), pantoprazole related compound C (PC) and pantoprazole related compound DandF (PDF), it can be employed as stability-indicating method for the determination of instability of the drug in bulk and pharmaceutical formulations.
KEYWORDS:
Liquid chromatography; Pantoprazole; stability indicating; Drug product.
Cite:
Paluru Rudra Mohan Reddy, J Sreeramulu, Petla Y. Naidu, A. Rajasekhara Reddy. Stability indicating Fast LC method for the estimation of impurities of Pantoprazole in Tablet Dosage Forms. Asian J. Research Chem. 3(3): July- Sept. 2010; Page 600-603.
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