Development and Validation of Analytical Methods for the Estimation of Few Drugs in Pharmaceutical Dosage Forms and Biological Fluids

Abstract

Once a new drug candidate has been identified for development and clinical trial, physicochemical methods are called in to play at every stage of the development program. Quality assurance plays a central role in determining the safety and efficacy of medicines. In this study Glimepride, Pioglitazone and Metformin in combined dosage form was estimated by proposed RP-HPLC and HPTLC method. Among the two methods RP-HPLC method was found to be more sensitive, precise and accurate. The Validation studies establish the efficiency of the method. The main advantage of the proposed method is, its suitability and routine determination of these three drugs in combined dosage form. High performance thin layer chromatographic method is rapid, simple and precise for Quantification of these drugs in combined dosage form. However, both the methods can be applied for toxicological and Therapeutic Drug monitoring studies. Sitagliptin and Metformin were estimated by developed RP-HPLC and HPTLC method. Among the two methods RP-HPLC method was found to be more sensitive, precise and accurate. HPTLC method is simple and cost effective and used for routine quality control studies and bioequivalence studies. Sitagliptin and Simvastatin were estimated by developed High performance thin layer chromatographic method. This method was found to be simple and precise, accurate and rebust method and can be employed successfully for the estimation of Sitagliptin and Simvastatin in combined dosage form. Balofloxacin was estimated by developed UV, HPTLC and UPLC methods. Among the three methods developed UPLC method was found to be more sensitive. The recovery values were also good for this method. However, all the methods can be applied for routine estimation of Balofloxacin in pharmaceutical formulation. The developed methods were useful in estimation of the combined dosage form and single dosage form in pharmaceutical formulations and from plasma. These developed methods were very simple, rapid, precise and provides accurate results.