RP-HPLC Method Development and Validation for Estimation of Metformin, Sitagliptin and Saxagliptin in Combined dosage Form

D. Komala*¹, K. Sunil Kumar², Dr. A. Dinakar Reddy^3
1Department of Pharmaceutical Analysis, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
²Associate Professor, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
³Professor& Principal, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

Abstract
A new method was established for simultaneous estimation of Metformin, Sitagliptin and Saxagliptin RP-HPLC method. Metformin Sitagliptin was freely soluble in water and alcohol. Saxagliptin was freely soluble in alcohol and sparingly soluble in water. Methanol and potassium dihydrogen ortho phosphate (pH3) was chosen as the mobile phase. The run time of the HPLC procedure was 5 minutes. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness robustness, LOD and LOQ. The system suitability parameters were within limit, hence it was concluded that the system was suitable to perform the assay. The method shows linearity between the concentration range of 10-100µg / ml. The % recovery of Metformin Sitagliptin and Saxagliptin were found to be in the range of 99.25%-98.22%. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in Flow rate and Mobile phase composition separately and analysis being performed by different analysts.        
Keywords: Metformin, Sitagliptin and Saxagliptin, RP-HPLC, Methanol.