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Asian Journal of Pharmaceutical Analysis
Year : 2016, Volume : 6, Issue : 3
First page : ( 151) Last page : ( 154)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2016.00024.7

Development and Validation of RP-HPLC method for simultaneous Estimation of Metformin HCl and Gliclazide

Pawar Jayshree, Sonawane Sandeep*, Chhajed Santosh, Kshirsagar Sanjay

Department of Pharmaceutical Analysis, MET's Institute of Pharmacy, Bhujbal Knowledge City, Adgaon, Nashik-422 003

*Corresponding Author E-mail: sandeeps.iop@gmail.com

Online published on 18 October, 2016.

Abstract

A new, simple and validated RP-HPLC method was developed for simultaneous estimation of Metformin HCl (MET) and Gliclazide (GLZ). The separation was achieved by using mobile phase Methanol: 10 mM Phosphate buffer (pH 3) 70: 30% v/v on Kinetics C18 column (250 × 4.6 mm, 5μ). The flow rate was 1 ml/min. The detection was carried out at wavelength 230 nm. The retention time of MET and GLZ was found to be 2.20 min and 4.67 min, respectively. Calibration curves for MET and GLZ were found to be linear in the range of 10–60 μg/ml and 2–12 μg/ml, respectively. The proposed method was validated as per ICH guideline Q2 (R1). The validation parameters studied were linearity, accuracy, precision, specificity and robustness. All validation parameters were found within the acceptable range.

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Keywords

Metformin HCl, Gliclazide, RP-HPLC, Analytical Method Validation.

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