Method Development and Validation of Newer Analytical Methods as per ICH Guidelines

Abstract

The proposed analytical methods are simple, accurate and reproducible. The advantages lie in the simplicity of sample preparation and the cost economic reagents used. The single/combined dosage forms selected for the present study are Sonidegib, Sacubitril and Valsartan, Emtricitabine and Tenofovir alafenamide and Perindopril arginine and Amlodipine besylate in capsule/tablets. These combinations have recently entered into the market. Sonidegib is used as an Anticancer agent. Sacubitril and Valsartan combination is used as an Antihypertensive agent. Emtricitabine and Tenofovir alafenamide combination is used as an Antiretroviral agent. In the view of literature cited for the estimation of above mentioned single/combination of drugs, it was found that the methods for the estimation of Sonidegib, Sacubitril, Valsartan, Emtricitabine, Tenofovir alafenamide, Perindopril arginine and Amlodipine besylate in capsule/tablets single or combined with other drugs were available. There is no method was available for the determination of the single/combined dosage forms with the solvents employed for the analytical studies. The aim of my present work is to develop a precise accurate and simple methods for the estimation of Sonidegib, Sacubitril and Valsartan, Emtricitabine and Tenofovir alafenamide and Perindopril arginine and Amlodipine besylate in API and in single or combined formulation and to validated the developed methods by Ultra-Violet Spectrophotometry, Reverse Phase High-Performance Liquid Chromatography and High-Performance Thin Layer Chromatography or by any two methods. The overall scope and plan of the research work is to develop the methods for new drug combinations enter into the market and to validate the newer analytical methods as per International Conference on Harmonisation (ICH) guidelines. In developed methods the various parameters used to validate are: Linearity, Precision, Range, Reproducibility, Repeatability Accuracy, Limit of Quantitation, Limit of Detection and Ruggedness.