Friday , 23 August 2019

Development and Validation of New UV Spectroscopic and HPLC Methods for the Estimation of Zidovudine in Bulk and Pharmaceutical Dosage Form

Telugu Naga Mohan, Shaik Mohammed Yusuf*, Seerla Eswaraiah, D. Chinna Raju, E. Vijay Kumar
Srinivasa Institute of Pharmaceutical sciences, Proddatur, YSR Kadapa [Dist]. AP. India. 

A B S T R A C T
In the present work, two simple, sensitive and specific methods (UV Spectroscopy and RP-HPLC) have been developed for the quantitative estimation of Zidovudine in bulk and pharmaceutical formulations. A UV Spectroscopic method was developed and validated for the estimation of Zidovudine in pharmaceutical dosage forms. The working standard solution was prepared in methanol. The λmax was found to be 266 nm. The linearity was found in the concentration range of 2-20 µg / ml. The Correlation coefficient was 0.999. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation, robustness and ruggedness. The limit of detection and limit of quantitation for estimation of Zidovudine was found to be 0.195 (µg / ml) and 0.585 (µg / ml), respectively. Recovery of Zidovudine was found to be in the range of 100.38-101.47 %. A simple, specific, accurate, and precise reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of Zidovudine in pharmaceutical dosage forms. A Phenomenex Gemini C-18, 5-µm column having 250 x 4.6 mm i. d. in isocratic mode, with mobile phase containing Methanol: Water (20: 80, v/v) was used. The flow rate was 1 ml/min and effluents were monitored at 266 nm. Chromatogram showed the main peak at a retention time of 4.47 min. The method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation, robustness and ruggedness. The limit of detection and limit of quantitation for estimation of Zidovudine was found to be 0.331 (µg / ml) and 1.005 (µg / ml), respectively. Recovery of Zidovudine was found to be in the range of 98.06-100.90 %. Proposed methods were successfully applied for the quantitative determination of Zidovudine in pharmaceutical dosage forms.
Keywords: Zidovudine, Method validation, UV Spectroscopy, RP-HPLC, ICH guidelines.

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