DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF MYO-INOSITOL AND METFORMIN HYDROCHLORIDE IN BULK AND DOSAGE FORM
AbstractA simple, sensitive, specific, accurate reversed phase high performance liquid chromatographic method was developed for the simultaneous estimation of Metformin HCl and Myo-Inositol in bulk and pharmaceutical dosage form. RP-HPLC separation was achieved on C-18 (250mm x 4.6mm, 5µm) column. The mobile phase composed of Water: Acetonitrile: Methanol (50:30:20 % v/v/v) [HPLC Grade] at flow rate 1ml/min with UV detection at 228 nm. The mobile phase consists of Ph 4. The retention times of Myo-Inositol and Metformin HCl were found to be 4.627 min and 4.002 minutes respectively. Assay of Myo-inositol and Metformin Hydrochloride was found to be 99.86% and 99.82% respectively. This method can be successfully employed for simultaneous quantitative analysis of Metformin HCl and Myo-Inositol in bulk drugs and formulations. The results indicate that there is no interference from excipients for the proposed method, thus making the method simpler, less time consuming. Chromatography parameters were validated as per ICH guidelines and the method can be applicable for routine quantitative analysis of drugs in combined dosage form.
Article Information
18
2811-2819
633 KB
393
English
IJPSR
Pathan Mahek Firoz Khan *, Sachin S. Rane and Vijay R. Patil
Department of Pharmaceutical Chemistry, TVES’s Honorable Loksevak Madhukarrao Chaudhari College of Pharmacy, Faizpur, Yawal, Jalgaon, Maharashtra, India.
mahek125khan@gmail.com
30 April 2025
13 May 2025
14 June 2025
10.13040/IJPSR.0975-8232.16(10).2811-19
01 October 2025