VALIDATED STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF CAPECITABINEAbstract
A new stability-indicating high-performance liquid chromatographic method of analysis of capecitabine in pharmaceutical dosage form was developed and validated. The solvent system consisted of methanol: water (60:40% v/v). The retention time of capecitabine was 7.927 min at a flow rate of 1 ml/min on C-18 (Quails BDS, 250 × 4.6 mm, 5µ). Capecitabine was detected at 240 nm. The linear regression analysis data for the linearity plot showed good linear relationship with the correlation coefficient value, R2 = 0.9991 in the concentration range 4-50 µg/ml. The method was validated according to the ICH guidelines. The accuracy of the method was validated by recovery studies and was found to be significant and under specification limits, with Recovery 98.12-101.61%. The assay of capecitabine was determined in tablet dosage form. The method was also found to be robust. The drug was subjected to stress conditions of acidic, basic, oxidation, photolytic and thermal degradation, and considerable degradation was found in all stress conditions. The method has proven specificity for the stability-indicating method.
K. V. Lalitha *, J. R. Reddy and N. Devanna
Division of Pharmaceutical Analysis and Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research (RIPER) - Autonomous Ananthapuramu, Andhra Pradesh, India.
19 November 2019
30 January 2020
13 March 2020
01 November 2020