METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND STAVUDINE BY RP-HPLC

Mr. Syed Wiquar M. Ahmed, Mr. Sameer S. Ahmed, Mr. Vishal R. Rasve*, Mr. Sugriv R. Ghodake, Mahesh Thakare

ABSTRACT

Pharmaceutical analysis comprises those procedures necessary to determine the “identity, strength, quality and purity” of the drug. Again it may be defined as the application of analytical procedures used to determine the purity, safety and quality of drugs and chemicals. It also deals the analysis of raw materials and intermediates in the manufacture of drugs. The pharmaceutical analyst must therefore, have a firm background in basic organic analysis and in addition he should have special skills in the quality evaluation of drug products. Pharmaceutical analysis include both qualitative and quantitative analysis of drugs and pharmaceutical substances which starts from bulk drugs (starting materials to the finished dosage forms) which is applied for identifying or quantifying constituents in a sample. During the optimization stage, the initial sets of conditions that have evolved from the first stages of development are improved or maximized in terms of resolution and peak shape, plate counts asymmetry, capacity, elution time, detection limits, limit of quantitation and overall ability to quantify the specific analyte of interest.The mean percentage recovery above 95% indicates the reproducibility and accuracy of new developed method compared. The result of study include the proposed method is highly accurate, simple, precise and specific. The simple recoveries in all formulations were in good agreement with their respective label claims. And they suggest non-interference of formulation excipients in the estimation.

Keywords: Lamivudine, Stavudine, RP-HPLC, Optimization, Pharmaceutical analysis, Accuracy etc.