METHOD DEVELOPMENT AND VALIDATION BY RP-HPLC FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND VILDAGLIPTINE IN PHARMACEUTICAL DOSAGE FORM

Ch. Srinivas*, Ch. Anil Kumar, B. Nagaraju and J. Nagajyothi

ABSTRACT

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In present experimentation the standard preparations were made from the API and sample preparations are from formulation. Both sample and standards are injected six homogeneous samples. Drug in the formulation was estimated by taking the standard as the reference. The average percentage assay was calculated and found to be 99.87% and 100.16 % for Metformin and Vildagliptin respectively. A simple, accurate, precise method was developed for the simultaneous estimation of the Metformin and Vildagliptin in Tablet dosage form. Retention time of Metformin and Vildagliptin were found to be 2.8min and 4.0min. % RSD of the Metformin and Vildagliptin were and found to be 0.65 and 0.9 respectively. % Recover was Obtained as 99.83% and 99.97% for Metformin and Vildagliptin respectively. LOD, LOQ values are obtained from regression equations of Metformin and Vildagliptin were 0.4ppm, 1.3ppm and 0.8ppm, 2.5ppm respectively. Regression equation of Metformin is y = 13779x + 1840, and of Vildagliptin is y = 16828x + 4143.

Keywords: Validation, API, homogeneous, simultaneous estimation, LOD, LOQ etc.