DEVELOPMENT AND VALIDATION OF RP-HPLC AND UV SPECTROPHOTOMETRIC METHODS FOR THE QUANTIFICATION OF CAPECITABINE
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 5
Abstract
Objective: The objective of the present study was to develop and validate a new liquid chromatographic technique and four new spectrophotometric methods for the quantitative estimation of Capecitabine.Methods: In the first method, the chromatographic technique was carried out in isocratic technique on Shimadzu Model CBM-20A/20 Alite HPLC system, equipped with SPD M20A prominence PDA detector with Zorbax C18 (150 mm × 4.6 mm i. d, 5 µm particle size) column. The method was optimized with a mobile phase consisting of 0.1 % Acetic acid and Acetonitrile (35:65, v/v) with flow rate 0.5 ml/min. In second, third, fourth and fifth methods, spectrophotometric techniques were applied. The absorption maximum (λmax) was observed at 305 nm, 305 nm, 303 nm and 297 nm for method B (developed in 0.1 N hydrochloric acid), C (developed in sodium acetate buffer pH 4.0), D (developed in phosphate buffer pH 7.0) and E (developed in borate buffer pH 9.0) respectively. Different validation parameters such as linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ), robustness were also determined.Results: The linearity of the calibration curves for the analyte in the desired concentration range is good for both the HPLC (R2 = 0.9994) and UV methods. The LOD and LOQ were found to be 0.02354 μg/ml and 0.07162 μg/ml respectively. The % RSD values for the validation parameters (precision and accuracy) were less than 2.0%.Conclusion: The proposed chromatographic and spectrophotometric methods were validated and can be applied for the determination of Capecitabine in pharmaceutical formulations.Keywords: Capecitabine, UV spectrophotometric, ÂÂForced degradation, RP-HPLC, Method validation
Authors and Affiliations
Sumanta Mondal, Reddy Narendra, Debjit Ghosh, Seru Ganapaty
Keywords
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