Md. Salmasultana1, Asish Bhaumik*2, Hiroshima Kumari3, P. Lavanya4, A. Uma5, T. Haritha6
1,3,4Department of Pharmaceutical Analysis, Teja College of Pharmacy, Kodad, Nalgonda-508206, Telangana, India.
2,5,6Department of Pharmaceutical Chemistry, Teja College of Pharmacy, Kodad, Nalgonda-508206, Telangana, India.
A B S T R A C T
The main aim and objective of the present research work was to develop a new UV/VISIBLE spectophotometric method for simultaneous estimation of Metformin and Sitagliptin, a new HPLC method for simultaneous estimation of Metformin and Sitagliptin, a validated method according to ICH guidelines and to apply validated method for the estimation of Metformin and Sitagliptin in pharmaceutical formulation. A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and Dapagliflozin in Tablet dosage form. Retention time of Metformin and Dapagliflozin were found to be 2.7min and 3.7min. %RSD of the Metformin and Dapagliflozin were and found to be 0.81 and 0.50 respectively. % Recover was Obtained as 99.74% and 100.53% for Metformin and Dapagliflozin respectively. LOD, LOQ values are obtained from regression equations of Metformin and Dapagliflozin were 1.30ppm, 0.43ppm and 3.95ppm, 1.31ppm respectively. Regression equation of Metformin is y = 20318x + 8024, and y = 12128x + 1591 of Dapagliflozin. Retention times are decreased and that run time was decreased so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
Keywords: HPLC, ICH, simultaneous estimation, LOD, LOQ