Journal of Chemical and Pharmaceutical Research

Introduction   Prior to the initiation of method development , all the known information about the analyte such as its structure, physical and chemical properties, toxicity, purity, hygroscopicity, solubility, and stability should be determined. These data may be available from preformulation reports, early drug discovery sample screening reports, from the literature on similar compounds, or from past experience with similar compounds. However, many times this information is not available, so preventive measures must be taken in order to ensure that the analyte does not degrade or change during the method development scouting experiments. Implementation of a tray cooler, preparation of fresh samples, storage of samples in a refrigerator, and protection of the solids and sample solutions from light represent some common preventive measures.

Abstract   A rapid, sensitive and specific RP-HPLC 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 suitabil...