RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF CAPECITABINE EXTENDED RELEASE TABLET DOSAGE FORMAbstract
A Simple, Rapid, Precise, Accurate, Robust and Stability indicating Reverse Phase HPLC method has been developed to estimate Capecitabine in tablet dosage form using mobile phase mixture consisting of Phosphate buffer : Acetonitrile (80:20) v/v at the flow rate of 1.2ml/min. The Hypersil BDS C8 column (250mm x 4.6mm x 5mm) was used as the stationary phase. The mobile phase was run for 15 min at the wavelength of 240 nm. The mean recovery was found to be 99.91%. The linearity range was 50% to 150% and was found to be successful under 0.999. The proposed method has fulfilled all the validation parameters such as linearity, Robustness, Accuracy, System Precision, intermediate precision, method precision, solution stability.
A. Santosh Kumar Sreevatsav* and A.K. Harishbabu
MRR Institute of Pharmacy, Nadergul, Saroornagar, Andhra Pradesh, India
30 May, 2013
26 September, 2013
01 November, 2013