Online ISSN: 2515-8260

METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE BY RP-HPLC

Main Article Content

Mrs. J. Raga Swetha1* , B. Lakshmi Kalyani1 , Dr.B.Chandra Sekhara Rao2 , Sakina Batool3 , Gundrathi Manjula4 ¸ Mofidul Islam5 , Gulchan Ali6 .

Abstract

ABSTRACT: A new simple, economical, sensitive, less-time consuming was developed and validated for the determination of metformin hydrochloride. The analysis complied with Beer’s law in the concentration range of 8-13 µg/mL at 233 nm for metformin hydrochloride by RP-HPLC & UV method Methanol, Acetonitrile, the proposed method was validated as per ICH guidelines parameters like linearity, specificity, precision, accuracy, robustness, degradation studies, absorption maximum, LOD & LOQ. The accuracy of methods was evaluated by recovery studies and good recovery results were obtained. The maximum absorption of metformin hydrochloride was found to be 236.40nm, in Methanol, Acetonitrile, Water (1:3:6). The linearity was found to be with the range of 0.005-1.0. The limits of accuracy were found to be within the limits of 98-110%. The results obtained showed a good agreement with the declared contents in case of pharmaceutical formulations. The method was also applied for the degradation studies. The development method is successfully validated for the estimation of metformin hydrochloride in bulk and dosage forms.

Article Details