Development and Validation of Discerning Analytical Quantification Methods for Some Drugs in Pharmaceutical Dosage Forms

Abstract

The present research work entitled Development and validation of Discerning analytical quantification methods for some drugs in pharmaceutical dosage forms presents the research accomplished for the establishment of novel analytical methods for quantification of multi-component and single drug in their pharmaceutical dosage forms. The proposed study comprised of three major parts, which consists of chemometric optimization to develop new method for determination of combination drug, HPLC method development and Ultra-Violet spectrophotometric method development and validation of the developed methods for the estimation of different drugs in pharmaceutical formulations. The chemometric tools of statistical experimental design methodology and derringer s desirability function were employed to develop a new simultaneous RP-HPLC method for the determination of chlorzoxazone, paracetamol and aceclofenac combination in combined tablet dosage form. The time of analysis, resolution and quality of peaks were concurrently optimized by using the above tools. The experimental design has been utilized during the development of the method to minimize the retention times and maximize the resolution. A total desirability function has been used to evaluate more than one response at a time and optimum condition was found by plotting response graphs. The data revealed that the method is simple, more sensitive and is optimal for the analysis of the drug combination, paracetamol, aceclofenac and serratiopeptidase in their combined pharmaceutical dosage form. The developed method is a direct UV spectrophotometric method without derivatization, extraction and evaporation for simultaneous estimation of paracetamol, aceclofenac and serratiopeptidase. Hence it is concluded that the proposed assay method is new, simple, accurate, specific, robust, sensitive and economical. So, this method can be successfully employed in the routine analysis of paracetamol, aceclofenac and serratiopeptidase in combined commercial dosage forms.