A. Satya Raga Devi, S. Ashutosh Kumar, J. Saravanan, Manidipa Debnath, V. Greeshma, N. Sai Krishna, Ch. Naga Madhusudhan Rao
A. Satya Raga Devi*1, S. Ashutosh Kumar1, J. Saravanan2, Manidipa Debnath3,
V. Greeshma2, N. Sai Krishna2, Ch. Naga Madhusudhan Rao1
1Department of Pharmaceutical Analysis and Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
2Department of Pharmacology, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
3Department of Pharmaceutics, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P
Volume - 7,
Issue - 2,
Year - 2014
Objective: Metformin is a biguanide antihyperglycemic agent used for treating non-insulin- dependent diabetes mellitus (NIDDM). It improves glycemic control by decreasing hepatic glucose production, decreasing glucose absorption and increasing insulin-mediated glucose uptake. Metformin is the only oral antihyperglycemic agent that is not associated with weight gain. Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating beta cells of the pancreas to release insulin. Method: This study was designed to develop and validate a simple, sensitive, precise, and specific reverse phase high-performance liquid chromatographic (HPLC) method for the determination of Metformin [MFH] and Gliclazide [GZ] combination drug in its tablet dosage forms. Result: The HPLC separation was carried out by reverse phase chromatography on XTerra column C18 (4.6 x 150mm, 5 micrometer) with a mobile phase composed mixture of 0.1% Orthophosporic Acid and Acetonitrile in the ratio of 35:65 v/v in isocratic mode at a flow rate of 0.8 ml/min. The run time was maintained 6mins. The detection was monitored at 230 nm. The retention time was 1.7min for [MFH] and 3.2min for [GZ]. The Accuracy was calculated and the % Recovery was found 98.0%-102.0% and reproducibility was found to be satisfactory .The calibration curve was linear over the concentration range of 20-60 µg/ml for [MFH] and 3.2-9.6µg/ml for [GZ] was found to be within limits. Conclusion: The proposed method was adequate sensitivity, reproducibility, and specificity for the determination of [MFH] and [GZ] in its tablet dosage forms. The limit of detection and limit of quantification for [MFH] and [GZ] were found to be 0.018 µg/ml, 0.03 µg /ml and 0.005 µg /ml, 0.11µg /ml respectively. The present work was undertaken with the aim to develop and validate a rapid and consistent RP- HPLC in which the peaks will be appear with a short period of time as per ICH guideline. The proposed method is simple, fast, accurate, and precise for the quantification of [MFH] and [GZ] in the dosage form.
Cite this article:
A. Satya Raga Devi, S. Ashutosh Kumar, J. Saravanan, Manidipa Debnath, V. Greeshma, N. Sai Krishna, Ch. Naga Madhusudhan Rao. A New RP-HPLC Method Development for Simultaneous Estimation of Metformin and Gliclazide in Bulk as well as in Pharmaceutical Formulation by using PDA Detector. Research J. Pharm. and Tech. 7(2): Feb. 2014; Page142-150.