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Abstract

Development and Validation of Ultraviolet Spectroscopic Analytical Method for Biopharmaceutical Classification System Class IV Anticancer Drug, Paclitaxel

Author(s): V. Mishra, M. M. Tambuwala and Y. Mishra*
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab 144411, India, 1Lincoln Medical School, University of Lincoln, Brayford Pool, Lincoln LN67TS, United Kingdom, 2School of Bioengineering and Biosciences, Lovely Professional University, Phagwara, Punjab 144411, India

Correspondence Address:
Y. Mishra, School of Bioengineering and Biosciences, Lovely Professional University, Phagwara, Punjab 144411, India, E-mail: yachanamishra@gmail.com

The purpose of current research involved the development of a facile, precise, accurate, suitable, reproducible as well as robust ultraviolet spectroscopic method for assessment of paclitaxel. The spectrum of paclitaxel was scanned at 400-200 nm of range using a stock solution of paclitaxel (100 µg/ml) as reference solution and methanol:phosphate buffer solution (pH 7.4) (3:7) and methanol: phosphate buffer solution pH 7.4 (5:5) as blank. Linearity was assessed from the calibration curve prepared using solutions of concentration 2-20 µg/ml. The technique was validated by determining linearity, accuracy, precision, repeatability, limits of detection, limits of quantitation and ruggedness as per International Council for Harmonization Q2 (R1) guidelines. The absorbance maxima of paclitaxel was found to be 230 nm in the 2-20 µg/ml of range. The regression coefficient was found to be 0.9981 in methanol:phosphate buffer solution 7.4 (3:7) and 0.9976 in methanol:phosphate buffer solution 7.4 (5:5). Percent relative standard deviation of all specifications was found to be within the limits. This validated method can magnificently be executed in the assessment of paclitaxel.

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