Development & Validation for Simultaneous Estimation of Lamivudine and Zidovudine in Tablet by RP-HPLC Method

Objective: The present study highlights to develop and validate the RP-HPLC method and apply the method to tablet dosage form.

Background: Most human DNA polymerases are not affected and systemic toxicity of Lamivudine is low. Various analytical methods have been reported for the estimation of Lamivudine as alone as well as in combination with other drugs.

Method: A simple, rapid, economical, precise and accurate RP-HPLC method for simultaneous estimation of Lamivudine and Zidovudine in their combined dosage form has been developed.

Results: A reverse-phase high-performance liquid chromatographic method was developed for the simultaneous estimation of Lamivudine and Zidovudine. Their combined dosage form has been developed. The separation was achieved by LC - C18 column (150mm x 4.6mm, 5
m) and Water: Methanol (65:35v/v) as mobile phase, at a flow rate of 0.8 ml/min. Detection was carried out at 272 nm. The retention time of Lamivudine and Zidovudine was found to be 3.007 min and 4.647, respectively. The method has been validated for linearity, accuracy and precision. The assay method was found to be linear from 50% to 150% for Lamivudine and Zidovudine.

Conclusion: The developed method was found to be accurate, precise and rapid for the simultaneous estimation of Lamivudine and Zidovudine in their combined dosage form. The proposed method can be used for routine analysis of Lamivudine and Zidovudine in combined tablet formulation.