Journal :   Asian Journal of Research in Chemistry

Volume No. :   3

Issue No. :  4

Year :  2010

Pages :   1090-1094

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Stability Indicating Fast LC Method for the Estimation of Impurities in Cephalexin for Oral Suspension



Address:   Paluru Rudra Mohan Reddy1*, J Sreeramulu1, Petla Y. Naidu2 and A. Rajasekhara Reddy3
1Department of Chemistry, S.K. University, Anantapur 515003, India
2Hospira Healthcare India Pvt. Ltd., SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram District, Tamilnadu 602105, India
3Orchid 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 Cephalexin. The developed method utilizes the chemistry of sub 2-µm C-18 column and mobile phase consisting of Potassium dihydrogen phosphate buffer – acetonitrile with gradient elution, at a flow rate of 1.0 mL per minute. The detection was carried out at 254 nm. As there are no simple Fast LC methods reported for the estimation of Impurities/degradants of Cephalexin in Pharmaceutical formulations, the current method was developed and validated. 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 excipients used the powder for suspension was found. As the proposed method could effectively separate the drug from its degradants/impurities, it can be employed as stability-indicating method for the determination of instability of the drug in bulk and pharmaceutical formulations.
KEYWORDS:
Liquid chromatography; Drug product; Degradants; stability indicating;
Cite:
Paluru Rudra Mohan Reddy, J Sreeramulu, Petla Y. Naidu, A. Rajasekhara Reddy. Stability Indicating Fast LC Method for the Estimation of Impurities in Cephalexin for Oral Suspension. Asian J. Research Chem. 3(4): Oct. - Dec. 2010; Page 1090-1094.
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