DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR THE DETERMINATION OF ZIDOVUDINE AND ITS RELATIVE SUBSTANCES IN BULK

Abstract

A simple, specific, accurate and economic reverse phase liquid chromatographic method was developed for the estimation of Zidovudine and its Relative substances in bulk. The method has shown adequate separation of Zidovudine and its Relative substances. Separation was achieved on a Shimadzu RP-C18 ODS (250×4.6mm, 5μm) column at wavelength of 270 nm, using a mobile phase water and Methanol (70:30) in an isocratic elution mode at a flow rate of 1.0 ml/min. The retention time for Zidovudine and Relative substances is found to be 9.5, 11.03 and 3.5 min correspondingly. Quantitation was achieved with UV detection at 270 nm based on peak area with linear calibration curve at concentration range 5-25 μg/ml for Zidovudine, 1-5 μg/ml for Zidovudine impurity B and Zidovudine impurity C. The LOD's were 0.343μg/ml, 0.098 μg/ml and 0.776 μg/ml for Zidovudine and its Relative substances respectively. The LOQ's were found to be 1.04 μg/ml, 0.29μg/ml and 0.47 μg/m for Zidovudine and Relative substances. The proposed method is therefore suitable for purpose in quality-control laboratories for quantitative analysis of both the drugs individually and in combined dosage form, as it is simple and rapid with tremendous precision and accuracy.