A very simple, accurate, precise, robust, rugged and stability indicating method with gradient elution was developed for simultaneous estimation of Empagliflozin and Linagliptin by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Empagliflozin and Linagliptin by using C18 (Equisil BDS) column (4.6 × 250 mm) 5μ, flow rate was 0.7 ml/min, mobile phase ratio was (40:60 v/v) methanol: water, detection wavelength was 224 nm and 294 nm. The instrument used was SHIMADZU-HPLC system, Pump-HPD 20A, Detector-UV detector, Software-UV Probe. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The Linearity study of Empagliflozin and Linagliptin was found in concentration range of 20 μg-40 μg, 60 μg, 80 μg, 100 μg and 10 μg, 20 μg, 30 μg, 40 μg, 50 μg correlation coefficient (r2) was found to be 0.988 and 0.991, % recovery was found to be 99.1% and 99.6.LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.

Analytical method development and validation are the continuous and inter-dependent task associated with the research and development, quality control and quality assurance departments. High performance liquid chromatography (HPLC) has been widely used for years as an analytical method and is a key tool for the separation and analysis of pharmaceutical drugs, for drug monitoring and for quality assurance and life science research. Most of the drugs in multi component dosage forms can be analysed by HPLC method because of the several advantages like rapidity, specicity, accuracy, precision and ease of automation in this method. HPLC methods development and validation play important roles in new discovery, development, manufacture of pharmaceutical drugs and various other studies related to humans and animals. This review gives information regarding principle, types, instrumentation and along with various application of the method and Validation of HPLC method as per ICH Guidelines covers all the performance characteristics of validation, like Accuracy, precision, specicity, linearity, range and limit of detection, limit of quantication, robustness