Journal :   Asian Journal of Research in Chemistry

Volume No. :   11

Issue No. :  4

Year :  2018

Pages :   731-738

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Method Development and Validation of UV and RP-HPLC method for the estimation of Capecitabine in Bulk and Pharmaceutical Dosage Forms



Address:   K. Vijaya Sri*, K. Prajawala, S. Deepthi, K. Niharika
Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, (Affiliated to Osmania University) Maisammaguda, Secunderabad-500 014
*Corresponding Author
DOI No: 10.5958/0974-4150.2018.00129.3

ABSTRACT:
A simple, selective, rapid, precise and accurate for the UV and High performance liquid chromatographic method for determination of capecitabine in bulk and its pharmaceutical formulations. Same solvent used as UV and RP-HPLC method. The mobile phase consisting mixture of acetonitrile: water 0.1% ortho phosphoric acid (50:50) v/v. Eclipse C18 column (5 µm particle size x 4.6 × 250 mm) was used as a stationary phase and flow rate for 0.8ml/min. UV and HPLC analysis of capecitabine was carried out at a wavelength of 242nm. The linear regression analysis data for the calibration curve showed a good linear relationship with a correlation coefficient of UV/HPLC 0.999 and 0.998. The UV and HPLC of linear regression equation was y=0.167X-0.024 and .In HPLC method sharp peak of capecitabine at a retention time of 1.67min.Validation parameters were evaluated for the method according to the ICH (Q2R1) guidelines. The limit of detection and limit of quantification for the UV and HPLC method were 0.103 and 0.312 0.042 and 0.021 respectively. The %RSD values for Intra-day precision and Inter-day precision were found to be 0.31 % and 0.30% respectively. Accuracy of the method was determined through recovery studies which were found to be within 99-102.22% for both the methods. In HPLC method precision, accuracy, sensitivity, short retention time and composition of the mobile phase indicated that this method is better than the earlier methods developed for the quantification of capecitabine in bulk and pharmaceutical dosage form.
KEYWORDS:
Capecitabine, method development, UV, RP-HPLC, Validation.
Cite:
K. Vijaya Sri, K. Prajawala, S. Deepthi, K. Niharika. Method Development and Validation of UV and RP-HPLC method for the estimation of Capecitabine in Bulk and Pharmaceutical Dosage Forms. Asian J. Research Chem. 2018; 11(4):731-738.
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