Development and Validation of a New Method for the Simultaneous Estimation of Metformin and Linagliptin in Bulk and Dosage form by using UV–Spectrophotometry

M. Mallikarjuna*, C. Guru Sudhakar, K. Siva Shankar, SK. Abid, P. Rameeja
Ratnam Institute of Pharmacy, Pidathapolur, Nellore, AP, India

ABSTRACT
A Simple, Determined, and precise method to develop a new quantitative simultaneous identification of metformin hydrochloride and Linagliptin in combined pharmaceutical dosage forms. This method was based on the based on the UV spectrophotometric method for the simultaneous estimation of two pharmaceutical dosage forms (metformin &Linagliptin) in combined and individual bulk and dosage forms. The drugs that are used in this development are treated for the abnormal metabolic condition pancreas or insulin metabolism called as type – II diabetes mellitus. It involves absorbance measurement at 232nm (ʎ max of Metformin) and 241nm (ʎ max of Linagliptin) in 0.1 M NaOH: CH₃OH (70: 30 v/v). For UV Spectrophotometric method, linearity was obtained in concentration range of 1-50µg/ml for metformin and 1-25µg/ml for Linagliptin respectively, with regression 0.995and 0.999 for metformin and Linagliptin with respect. Recovery was in the range of 98-101%; the standard deviation and % RSD were found to be < 2 %; shows the high precision of the method, in accordance with ICH guidelines. The method has been successively applied to pharmaceutical formulation and was validated according to ICH guidelines.
Keywords: UV Spectrophotometer, Diabetes mellitus, Metformin HCl, Linagliptin, ICH