UV Spectrophotometric Development and Validation of Zidovudine API and in Marketed Zidovudine Tablet Dosage form
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To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of zidovudine API and in zidovudine tablet dosage form. The UV spectroscopic method was developed for estimation of zidovudine API and in zidovudine tablet dosage form and also validated as per ICH guidelines. The different solvent blends viz., Saline phosphate buffer pH 7.2(Method-I); Methanol: Water: 0.1N HCl (3: 1: 1) (Method-II); Methanol: Water: 0.1N NaOH (3: 1: 1) (Method-III) were selected. It showed absorption maxima 267 nm for all three different methods. The linearity was observed between 1–18 μg/ml in Method-I, 120 μg/ml in Method-II and 1–16 μg/ml in Method-III, with correlation coefficient of 0.9998. The results of the analysis were validated by recovery studies. The recovery was found to be 99.9±0.750, 100.2±1.114, 98.8±1.635 with % RSD values of 0.750, 1.111, 1.635 for Method-I, Method-II and Method-III respectively which were within the acceptance limit. The % RSD values of intraday precision for zidovudine in formulations were found to be 0.554, 0.532, 0.437 and % RSD values of inter day precisions for zidovudine were found to be 1.354, 1.659, 1.406 for Method-I; Method-II and Method-III respectively which were within the acceptance limit. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of zidovudine API and zidovudine tablet dosage form. The method could be considered for the determination of zidovudine in quality control laboratories.
UV Spectrophotometer, Validation, Accuracy, Linearity, Ruggedness, Precision.