


Volume 20 No 20 (2022)
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Method Development and Validation for Simultaneous Estimation of Metform in Hydrochloride and Nateglinide by Rp-Hplc Method in Its Pure and Tablet Dosage Form
Dr. Srinivas Ganta, Dr. R. Vijay Kumar, Surya Prakash Rao Pydimarry, Dr. A. Madhukar, Haneefunnisa
Abstract
A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin Hydrochloride (MET) and Nateglinide (NAT) in Tablet dosage form. Chromatogram was run through Symmetry C18 (150 x 4.6 mm, 3.5) Mobile phase containing Ammonium Acetate and Methanol taken in the ratio 35:65 was pumped through column at a flow rate of 1.6 ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 256.0 nm. Retention time of MET and NAT were found to be 2.804 min and 3.875 min. %RSD of the MET and NAT were and found to be 0.99 and 0.42 respectively. The method is linear over a concentration range of 10 to 50 µg/ml for MET and 60 to 300 µg/ml for NAT. The method was accurate with a %Recovery of98.6 to 99.7% and 99.87 to 100.2 % for MET and NAT respectively. The method developed is robust after making deliberate changes in flowrate, change in mobile are composition with a % RSD less than 2.Limit of Detection was found to be 0.015,&0.396µg/ml for MET and NAT respectively. Limit of Quantification was found to be 0.045,&1.18µg/ml for MET and NAT. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be utilized in regular analysis of dosage forms containing MET and NAT.
Keywords
Metformin Hydrochloride (MET),Nateglinide (NAT),Stability indicating studies, RP-HPLC.
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