Journal :   Asian Journal of Research in Chemistry

Volume No. :   4

Issue No. :  5

Year :  2011

Pages :   810-814

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Development and Validation of RP-HPLC Method for Estimation of Impurities of Cefprozil in its Powder for Oral Suspension Dosage form Using Sub 2-µm Column



Address:   P. 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 reversed-phase high-performance liquid chromatographic method for separation and quantification of impurities of Cefprozil powder for oral suspension dosage form has been developed and validated. Chromatography was performed on a 100 x 4.6 mm, 1.8-µm particle, C18 column with mobile phase-A, 0.23 % Ammonium dihydrogen orthophosphate in water and mobile phase-B, 80 : 20 (v/v) Methanol – mobile phase-A by gradient elution. The system was operated at 0.6 mL min-1 mobile phase flow rate and the column thermostat was maintained at 25ºC. UV detection was performed at 290 nm. Forced degradation studies were conducted on Drug product using ICH stress study guidelines to demonstrate the specificity and stability-indicating nature of the method. The method was validated for precision, accuracy, linearity, specificity and sensitivity in accordance with ICH guidelines. LOD and LOQ for individual impurities were below 0.014 and 0.037 % (w/w) respectively. Validation revealed the method is specific, precise, accurate, linear, robust and reproducible.
KEYWORDS:
RP-HPLC, Cefprozil, validation, forced degradation.
Cite:
P. Rudra Mohan Reddy, J. Sreeramulu, Petla Y Naidu, A. Rajasekhara Reddy. Development and Validation of RP-HPLC Method for Estimation of Impurities of Cefprozil in its Powder for Oral Suspension Dosage form Using Sub 2-µm Column. Asian J. Research Chem. 4(5): May, 2011; Page 810-814.
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