AJAC  Vol.2 No.2 , May 2011
Determination of Glimepiride in Rat Serum by Rp-Hplc Method
Abstract: A simple and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of glimepiride in rat serum. The assay involves one step liquid-liquid extraction with methanol. Gliclazide was used as an internal standard. Chromatographic separation was performed on a C18 column using a mobile phase of methanol: 10mM phosphate buffer (80:20 v/v) adjusted to pH 3.0 with orthophosphoric acid, at a flow rate of 1.0 ml/min and UV detection at 230 nm. The retention time of glimepiride and gliclazide was found to be 5.5 and 4.0 min and separation was complete in less than 10 min. The method was validated for linearity, accuracy and precision were found to be acceptable over the range of 0.5 - 500 µg/mL for glimepiride. The method was found suitable to analyse rat serum samples for application in pharmacokinetic, pharmacodynamic, bioavailability/bioequivalence studies.
Cite this paper: nullS. Samala, S. Tatipamula and C. Veeresham, "Determination of Glimepiride in Rat Serum by Rp-Hplc Method," American Journal of Analytical Chemistry, Vol. 2 No. 2, 2011, pp. 152-157. doi: 10.4236/ajac.2011.22017.

[1]   A. L. McCall, “Clinical Review of Glimepiride,” Expert Opinion on Pharmacotherapy, Vol. 2, No. 4, 2001, pp. 699-713. doi:10.1517/14656566.2.4.699

[2]   J. Rosenstock, E. Samols, D. B. Muchmore and J. Schneider, “Glimepiride, a New Once-Daily Sulfonylurea: A Double-Blind Placebo-Controlled Study Of NIDDM Patients,” Diabetes Care, Vol. 19, No. 11, 1996, pp. 1194-1199. doi:10.2337/diacare.19.11.1194

[3]   S. N. Davis, “The Role of Glimepiride in the Effective Management of Type 2 Diabetes,” Journal of Diabetes and its Complications, Vol. 18, No. 6, 2004, pp. 367-376. doi:10.1016/j.jdiacomp.2004.07.001

[4]   D. S. Bell, “Practical Considerations and Guidelines for Dosing Sulfonylureas in Monotherapy or Combination Therapy,” Clinical Therapeutics, Vol. 26, No. 11, 2004, pp. 1714-1727. doi:10.1016/j.clinthera.2004.10.014

[5]   M. Badian, A. Korn, K. H. Lehr, V. Malerczyk and W. Waldhausl, “Determination of the Absolute Bioavailability of Glimepiride (HOE 490), a New Sulfonylurea,” International Journal of Clinical Pharmacology, Therapy and Toxicology, Vol. 30, No. 11, 1992, pp. 481-482.

[6]   M. E. Roche, R. P. Oda, G. M. Lawson and J. P. Landers, “Capillary Electrophoretic Detection of Metabolites in the Urine of Patients Receiving Hypoglycemic Drug Therapy,” Electrophoresis, Vol. 18, No. 10, 1997, pp. 1865-1874. doi:10.1002/elps.1150181024

[7]   J. N. Jingar, S. J. Rajput, B. Dasandi and S. Rathnam, “Development and Validation of LC-UV for Simultaneous Estimation of Rosiglitazone and Glimepiride in Human Plasma,” Chromatographia, Vol. 67, No. 11-12, 2008, pp. 951-955. doi:10.1365/s10337-008-0633-3

[8]   Y. K. Song, J. E. Maeng, H. R. Hwang, J. S. Park, B. C. Kim, J. K. Kim and C. K. Kim, “Determination of Glimepiride in Human Plasma Using Semi-Microbore High-Performance Liquid Chromatography with Columnswitching,” Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Vol. 810, No. 1, 2004, pp. 143-149.

[9]   I. U. Khan, F. Aslam, M. Ashfaq and M. N. Asghar, “Determination of Glimepiride in Pharmaceutical Formulations Using High-Performance Liquid Chromatography and First-Derivative Spectrophotometric Methods,” Journal of Analytical Chemistry, Vol. 64, No. 2, 2009, pp. 171-175. doi:10.1134/S1061934809020130

[10]   I. I. Salem, J. Idrees and J. I. Al Tamimi, “Determination of Glimepiride in Human Plasma by Liquid Chromatography—Electrospray Ionization Tandem Mass Spectrometry,” Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, Vol. 799, No. 1, 2004, pp. 103-109. doi:10.1016/j.jchromb.2003.10.024

[11]   H. Kim, K. Y. Chang, H. J. Lee and S. B. Han, “Determination of Glimepiride in Human Plasma by Liquid Chromatography—Electrospray Ionization Tandem Mass Spectrometry,” Bulletin of the Korean Chemical Society, Vol. 25, No. 1, 2004, pp. 109-114. doi:10.5012/bkcs.2004.25.1.109

[12]   H. Kim, K. Y. Chang, C. H. Park, M. S. Jang, J. A. Lee, H. J. Lee and K. R. Lee, “Determination of Glimepiride in Human Plasma by LC-MS-MS and Comparison of Sample Preparation Methods for Glimepiride,” Chromatographia, Vol. 60, No. 1-2, 2004, pp. 93-98. doi:10.1365/s10337-004-0351-4

[13]   N .Yuzuak, T. Ozden, S. Eren and S. Ozilhan, “Determination of Glimepiride in Human Plasma by LC-MS-MS,” Chromatographia, Vol. 66, No. 1, 2007, pp. 165-168. doi:10.1365/s10337-007-0368-6

[14]   S. P. Pawar, G. A. Meshram and M. U. Phadke, “Simultaneous LC Estimation of Glimepiride and Metformin in Glimepiride Immediate Release and Metformin Sustained Release Tablets,” Chromatographia, Vol. 68, No. 11-12, 2008, pp. 1063-1066. doi:10.1365/s10337-008-0802-4

[15]   K. H. Lehr and P. Damm, “Simultaneous Determination of the Sulphonylurea Glimepiride and Its Metabolites in Human Serum and Urine by High-Performance Liquid Chromatography after Pre-Column Derivatization,” Journal of Chromatography-Biomedical Applications, Vol. 526, No. 1, 1990, pp. 497-505. doi:10.1016/S0378-4347(00)82531-1

[16]   The United States Pharmacopeia (USP) and the National Formulary (NF), “The Official Compendia of Standards,” Vol. 29, No. 2, 2006, p. 1001.

[17]   D. B. Pathare, A. S. Jadhav and M. S. Shingare, “RP-LC Determination of the Cis-Isomer of Glimepiride in a Bulk Drug Substance,” Chromatographia, Vol. 66, No. 7-8, 2007, pp. 639-641. doi:10.1365/s10337-007-0356-x