Method development and validation of RP-HPLC method for simultaneous determination of Lamivudine and Zidovudine


ABSTRACT:

A rapid, sensitive and specific RP-HPLC [1-5] method involving UV detection was developed and validated for determination and quantification of Lamivudine and Zidovudine. Chromatography was carried out on a pre-packed AltimaC18 5µ (150*4.6mm) column using filtered and degassed mixture of Ammonium acetate buffer:Methanol (80:20) as mobile phase at a flow rate of 1.0ml/min and effluent was monitored at 270nm. The method was validated in terms of linearity, precision, accuracy, and specificity, limit of quantification and limit of detection. The assay was linear over the concentration range of Lamivudine and Zidovudine was 37.5mcg-112.5mcg/ml and 75mcg to 225mcg/ml respectively. Accuracy of the method was determined through recovery studies by adding known quantities of standard drug to the pre analyzed test solution and was found to be 98.50%-99.9% and 98.30%- 100.10% within precision RSD of 0.71 and 0.82 for Lamivudine and Zidovudine respectively. The system suitability parameters such as theoretical plates and tailing factor were found to be 3189.33, 1.12 and 7852.83, 1.05 respectively for Lamivudine and Zidovudine. The method does require only 20 minutes as run time for analysis which prove the adoptability of the method for the routine quality control of the drug.

Further details @ http://www.jocpr.com/

For more details @ http://www.jocpr.com/articles/method-development-and-validation-of-rphplc-method-for-simultaneous-determination-of-lamivudine-and-zidovudine.pdf

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