ANALYTICAL QUALITY BY DESIGHN APPROACH FOR THE DEVELOPMENT OF VALIDATED RP-HPLC METHOD IN THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND TENOFOVIR DISPROXIL FUMERATE IN BULK AND THEIR COMBINED DOSAGE FORMS
SK. Mastanamma*, L. Prathibha, P. Saidulu, M. Varalakhimi and U. Annapurna
ABSTRACT
Qualitybydesign(QbD)referstotheachievementofcertainpredictablequalitywithdesired and predetermined specifications. A very useful component of the QbD is the understanding of factors and their interaction effects by a desired set of experiments. The present study describes the development of a comprehensive science and risk based RP-HPLC method and subsequent validation for the simultaneous analysis of Lamivudine and tenofovir disposil fumarate active pharmaceutical ingredients (API) using a quality by design approach. An efficient experimental design based on systematic scouting of all three key components of the RPHPLC method (column, pH and mobile phase) is presented. The described method was linear. ((r2) =0.9998).( linearity range =)The precision, ruggedness and robustness values were also within the prescribed limits (<1% for system precision and <2% for other parameters). Chromatographic peak purity results indicated the absence of co-eluting peaks with the main peak of Lamivudine and tenofovir disposil fumarate. The proposed method can be used for routine analysis of Lamivudine and tenofovir disposil fumarate in quality control laboratories.
Keywords: Quality by design, HPLC, Lamivudine and tenofovir disposil fumarate.
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