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The objective of present work was to develop and validate a simple, accurate, precise stability indicating RP-HPLC method for the estimation of Metformin HCl and Linagliptin in pharmaceutical dosage form. The chromatographic separation was achieved on a Column C18 Inertsil ODS 3V (4.6×250 mm, particle size 5 μ). Different mobile phase systems in different proportions were tried. For HPLC method a mobile phase Acetonitrile and phosphate buffer (pH 4.6) in the ratio of 35:65% v/v. The detection was carried out using DAD detector set at a wavelength of 230 nm. Flow rate was 1.0 ml/min. The retention time was found to be 2.206 min and 4.487 min for Metformin and Linagliptin respectively. The proposed method was found to be excellent linearity in the concentration range of 100-600 μg/ml and 0.5-3 μg/ml with correlation coefficient r²= 0.999 and 0.999 for Metformin and Linagliptin. The method validated for accuracy, precision, linearity, LOD, LQD and robustness. The proposed method optimized and validated as per ICH guidelines. [ABSTRACT FROM AUTHOR]

Anti-diabetic drugs and their selection depend on the nature of the diabetes, age and situation of the person, as well as other factors. Diabetes mellitus type 1 is a disease caused by the lack of insulin. Diabetes mellitus type 2 is a disease of insulin resistance by cells. The present review summarizes the chemistry and pharmacological aspects of newly approved Segluromet™ (Ertugliflozin and metformin hydrochloride) tablet for oral use. metformin hydrochloride, a member of the biguanide class. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Inhibiting SGLT2, Ertugliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. Ertugliflozin was developed under the collaboration of Merck and Pfizer. It was approved US-FDA as monotherapy and in combination with metformin hydrochloride or Sitagliptin in Dec 2017. Combine Chemistry includes Ertugliflozin L-pyroglutamic acid is an white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water with Molecular formula C27H32ClNO10 molecular weight of 566g/mol. The pKa of Ertugliflozin 11.98. and Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63 g/mol. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. [ABSTRACT FROM AUTHOR]