Method development and validation of newer analytical techniques

Abstract

Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods. The combined dosage form selected for the present study containing those following combinations in tablets, recently these combinations of the drugs introduced in to the market. 1. Tolperisone hydrochloride and paracetamol 2. Simvastatin and sitagliptin phosphate 3. Thiocolchicoside and ketoprofen 4. Desloratadine and ambroxol hydrochloride 5. Doxofylline and salbutamol sulphate. The simultaneous estimation of two drugs in a formulation has more advantages such as accurate, less use of reagent and less time requirement for the simultaneous estimation rather than individual estimation of two drugs. Novel, simple, precise and accurate analytical techniques were developed for the following combinations and to validate the methods according to ICH guidelines and applying the same for its estimation in marketed formulation. The methods includes 1. UV spectroscopic method 2. RP-HPLC method 3. HPTLC method. The present work involves Simultaneous Estimation of Newer Analytical method for the new combination of drugs. The combination of drug most commonly refers to a fixed dose combination (FDC) which is formulation including two or more active pharmaceutical ingredients. By using the combination of drugs to analyse, it was more advantageous than the use of individual drug. The drugs were analysed to determine the purity, sensitivity and efficacy. newline