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Development and validation of rp-hplc method for simultaneous estimation of imeglimin and metformin used for The treatment of diabetes
Corresponding Author(s) : Adimulam Sailaja
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Imeglimin And Metformin, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Hypersil C18 (4.6×250mm) 5µ column using a mixture of Water and Acetonitrile (50:50) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 244nm. The retention time of the Imeglimin and Metformin was 2.0, 4.0±0.02min respectively. The method produce linear responses in the concentration range of 20-100µg/ml of Imeglimin and 40-200µg/ml of Metformin. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.
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- R. Snyder, J. Kirkland, L. Glajch. Practical HPLC method development, 2nd ed, A Wiley international publication, 1997, P.235, 266-268,351-353.653-600.686-695.
- Basic education in analytical chemistry. Analytical science, 2001:17(1).
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- Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.
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- H.H. Willard, L.L. Merritt, J.A. Dean, F.A. Settle. Instrumental methods of analysis, 7th edition, CBS publishers and distributors, New Delhi. 1986, P.518-521, 580-610.
- John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nd ed, P.74, 5-15.
- Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of chemical analysis, 5th edition, Himalaya publishing house, New Delhi, 2002, P.1.1-1.8, 2.566-2.570
- D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
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References
R. Snyder, J. Kirkland, L. Glajch. Practical HPLC method development, 2nd ed, A Wiley international publication, 1997, P.235, 266-268,351-353.653-600.686-695.
Basic education in analytical chemistry. Analytical science, 2001:17(1).
Method validation guidelines international Conference on harmonization; GENEVA; 1996
Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New work, 1993; 57:411-28
Anthony C Moffat, M David Osselton, Brian Widdop. Clarke’s analysis of drugs and poisons, Pharmaceutical press, London, 2004, P.1109-1110, 1601-1602.
Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.
P.N. Arora, P.K. Malhan. Biostatistics, Himalaya publishers house, India, P.113, 139-140,154.
Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23rd ed. Goel publishing house meerut, 2004, P12-23.
H.H. Willard, L.L. Merritt, J.A. Dean, F.A. Settle. Instrumental methods of analysis, 7th edition, CBS publishers and distributors, New Delhi. 1986, P.518-521, 580-610.
John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nd ed, P.74, 5-15.
Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of chemical analysis, 5th edition, Himalaya publishing house, New Delhi, 2002, P.1.1-1.8, 2.566-2.570
D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
Skoog, Holler, Nieman. Principals of instrumental analysis 5th ed, Harcourt publishers’ international company, 2001, P.543-554.
William Kemp. Organic spectroscopy, Palgrave, New York, 2005, P.7-10, 328-330
P.D. Sethi. HPLC: Quantitative analysis pharmaceutical formulations, CBS publishers and distributors, New Delhi (India), 2001, P.3-137.