Development and Validation of HPLC Methods for the Simultaneous Estimation of Drugs in a Few Multicomponent Dosage Forms

Abstract

This thesis deals with the studies carried out by the writer in this laboratory for the past four years on the development of high performance liquid chromatographic (HPLC) methods for the simultaneous estimation of drugs in a few multicomponent dosage forms. The first chapter begins with a brief account of the need for drug analysis and an introduction to HPLC. The methods used for the quantitative analysis and the steps involved in HPLC method development are presented. An introduction to the multicomponent dosage forms and the different methods of analysis used to estimate multicomponent dosage forms are given. The second chapter deals with the scope and object of the present investigation. The merits of HPLC method in estimating the multicomponent dosage forms are described. The estimation of multicomponent dosage forms by HPLC requires a proper method development and validation of the same. The objectives of the present study, namely, to optimise the chromatographic conditions, to develop methods to estimate the drugs in the twelve multicomponent dosage forms selected by HPLC methods developed and to validate the same, are explained. The third chapter deals with the materials and instruments used in the experimental procedures adopted. It describes in detail the procedure adopted for the optimisation of the chromatographic conditions for the separation of the drugs present in the multicomponent dosage forms, the actual estimation of the twelve multicomponent dosage forms and validation of the developed methods. The optimised chromatographic conditions are also presented and discussed. In the fourth chapter, the results obtained are presented and discussed. In particular, chromatograms obtained for the sample solutions, percentage label claim of the formulations analysed by the developed HPLC methods, accuracy, a reproducibility (intraday and interday variations), specificity, linearity and range, LOD and LOQ, A ruggedness and robustness, A stability and system suitability studies are discussed in detail.