Comparative study of qbd implementation perspective in india with other countries and application of aqbd in selected combined formulations

Abstract

quotBackground: Determination of drugs in combined pharmaceutical dosage forms without any interference from any common excipients is a major challenge faced today by many analysts. Quality is important in every product or service, but it is vital in medicines as it involves life. The present work describes simple, accurate and precise analytical methods for determination of selected combined dosage forms. newlineAim: To develop a simple, precise, and accurate Analytical methods by applying QbD approach for estimation of selected combined dosage forms and to validate the methods as per ICH guideline. newlineMaterials and Methods: Billargic M the fixed dose combination of Bilastine and Montelukast sodium, Efonta T fixed dose combination of Efonidipine Hydrochloride Ethanolate and Telmisartan, Efnocar CT fixed dose combination of Efonidipine Hydrochloride Ethanolate and Chlorthalidone was selected and raw materials were procured from the well-known sources. Instruments - UV, HPLC etc. will be used for analyzing the drug combinations. Various chemical like Acetonitrile, Methanol, Dipotassium phosphate buffer, OPA etc are used. newlineResults and Discussion: newlineA simple, accurate, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the simultaneous determination of Bilastine (BST) and Montelukast sodium (MNT), Efonidipine Hydrochloride Ethanolate (EFE) and Telmisartan (TLM), Efonidipine Hydrochloride Ethanolate and Chlorthalidone (CHL). By using 32 Factorial design, 23 Factorial design and central composite design method have been developed and optimized, respectively. newlineConclusion: The AQbD based developed methods for Bilastine and Montelukast sodium, Efonidipine Hydrochloride Ethanolate and Telmisartan, Efonidipine Hydrochloride Ethanolate and Chlorthalidone were successfully validated as per ICH Q2 (R1) and from the results it was concluded that the present method was suitable for the routine estimation of the raw materials and in the pharmaceutical formulation.quot