Analytical Method Development and Validation Protocol for Some Selected Anti Diabetics and Anti inflammatory Drugs

Abstract

newline New, simple, economic and stability indicating for methods were develped and validated for selected Ant diabetic and anti inflammatory drugs. Simple RP-HPLC methods were developed and validated for the quantitative estimation for Vildagliptin (VIL) and Metformin (MET), Lornoxicam (LOR) and Thiocolchicoside (THIO), Pioglitazone (PIO) and Metformin (MET) and Lornoxicam (LOR) and Paracetamol (PCM). To develop stability indicating RP-HPLC assay method, drugs were subjected to acid hydrolysis, alkali hydrolysis, neutral hydrolysis, chemical oxidation, and dry heat degradation and photo degradation conditions. The proposed methods was validated according to various ICH parameters like linearity, accuracy, precision, specificity, limits of detection, limits of quantification, range, solution stability and system. Simultaneous spectrophotometric estimation was carried out for same combinations. Simple HPTLC methods were developed and validated for the quantitative estimation of VIL and MET, LOR and THIO from bulk and its formulation along with stress degradation studies and validated as per ICH guidelines. newlineCombination -I: Vildagliptin (VIL) and Metformin (MET) newlineStability indicating RP-HPLC method was developed using C18 column as a stationary phase and acetonitrile and phosphate buffer (20:80 v/v, pH 7 adjusted with ortho phosphoric acid) as mobile phase. The flow rate was maintained at 1 ml/ min at 217 nm. The retention times of MET and VIL were 2.57 min and 7.06 min. The method was linear in the concentration of 100 600 and#956;g/ml and 10 60 and#956;g/ml respectively and obeys the beer s law. Stability indicating HPTLC method was developed using Silica gel GF254 as a stationary phase and Hexane: Methanol: Acetonitrile: Glacial Acetic Acid (2: 3.5: 2.5:0.2 v/v/v/v). The retardation factor (Rf) values of 0.22 ± 0.01 for metformin hydrochloride (MET) and 0.73 ± 0.02 for vildagliptin (VIL) was found. The detection was carried out at 217 nm. newlineFor the determination simultaneous equation method three absorbance maxima of