Abstract
A reverse phase HPLC method for the analysis of Zidovudine has been developed in bulk and pharmaceutical formulation. The developed method is also utilized to determine purity and quality of the market formulation drug by dissolution studies. The mobile phase consisted of methanol and water (89:11 v/v) showed retention time of 2.99 min with a flow rate of 1 mL/min at detection wavelength 266 nm. Linear regression analysis data for the calibration plot showed a good linear relationship between response and concentration in the range 25–350 µg mL−1; the regression coefficient was 0.9995 and the linear regression equation was y = 19.75x + 57.73. The detection (LOD) and quantification (LOQ) limits were 2.92 and 8.87 µg mL−1, respectively. The method was validated for accuracy, precision, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. Statistical analysis proved the method was precise, reproducible, selective, specific, and accurate for analysis of Zidovudine. The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quantification of Zidovudine with high precision and accuracy.
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