Abstract

Rosiglitazone (ROS) and Glimepiride (GLM) are widely used to treat Type 2 diabetes (T2DM). In order to investigate drug-drug interactions between ROS and GLM, a method was developed and validated for simultaneous determination of ROS and GLM in rat plasma employing solid-phase extraction for the separation of analytes and liquid chromatography-tandem mass spectrometry (LC-MS/MS) for quantitation. The compounds were eluted isocratically on a Zorbax SB-Phenyl column, ionized using an atmospheric pressure electrospray ionization source, and analyzed in positive ion mode with multiple reaction monitoring. The ion transitions monitored were 358.13 → 135.06 for ROS, m/z 491.5 → 352.6 for GLM, and m/z 271.3 →172.1 for the internal standard (IS: Tolbutamide). The chromatographic run time was 5 min per injection, with retention times of 1.92, 2.73, and 3.48 min for GLM, IS, and ROS, respectively. The calibration curves of ROS and GLM were over the range of 0.1-6.0 (r² > 0.999) and 0.05-3.0 µg/ml (r² > 0.9987) in the combined matrix of rat plasma and a mobile phase (60:40 (v/v) mixture of acetonitrile and 10 mM ammonium acetate buffer with 0.02% TFA (pH 3.00 ± 0.05). The results of the intra- and inter-day precision and accuracy studies were well within the acceptable limits. In addition, all the analytes were found to be stable in a group of stability studies. Thus, the method is precise and sensitive enough for its intended purpose. The developed assay method was successfully applied to a pharmacokinetic study in human male volunteers.

Keywords: Rosiglitazone; Glimepiride; LC-MS/MS; Pharmacokinetics; Method Validation; Chromatography

References

1. Karim A., et al. “Replicate study design in bioequivalency assessment, pros, and cons: bioavailabilities of the antidiabetic drugs pioglitazone and GLM present in a fixed-dose combination formulation”. The Journal of Clinical Pharmacology 47 (2007): 806-816.
2. Koski RR. “Oral Antidiabetic Agents: A Comparative Review”. Journal of Pharmacy Practice 17 (2004): 39-48.
3. Balfour JA and Plosker GL. “ROS”. Drugs6 (1999): 921-930.
4. AVANDARYL® (ROSIGLITAZONE maleate and GLM) Tablets.
5. Gomes P and Steppe M. “First-derivative spectrophotometry in the analysis of ROSIGLITAZONEin coated tablets”. Journal of AOAC International 89 (2006): 1296-1299.
6. Walash MI., et al. “Spectrofluorimetric and spectrophotometric determination of ROSIGLITAZONEmaleate in pharmaceutical preparations and biological fluids”. Pharmaceutical Chemistry Journal 43 (2009): 697-709.
7. El Sherbiny D., et al. “Voltammetric Determination of ROSIGLITAZONEin pharmaceutical preparations and human plasma”. Analytical Letter 41 (2008): 806-821.
8. Ali AR., et al. “Column high-performance liquid chromatographic method for the simultaneous determination of ROSIGLITAZONEand metformin in pharmaceutical preparation”. Journal of AOAC International 92 (2009): 119-124.
9. Kang X., et al. “A high-performance liquid chromatography method for simultaneous determination of ROSIGLITAZONEand gemfibrozil in human plasma”. Journal of Chromatography B: Biomedical Sciences 877 (2009): 645-648.
10. Yu J., et al. “Bioequivalence and comparison of pharmacokinetic properties of 4-mg tablet formulations of ROSIGLITAZONEhydrochloride and ROSIGLITAZONEmaleate: a single-dose, randomized, open-label, two-period crossover study in healthy adult male Chinese volunteers”. Clinical Therapy 30 (2008): 2272-2279.
11. ltinöz S and Tekeli D. “Analysis of GLM by using derivative UV spectrophotometric method”. Journal of Pharmaceutical and Biomedical Analysis 24 (2001): 507-515.
12. Ma HL., et al. “Polarographic behavior and determination of GLM”. Yao Xue Xue Bao 40.8 (2005): 750-753.
13. Karthik A., et al. “Simultaneous determination of pioglitazone and GLM in bulk drug and pharmaceutical dosage form by RP-HPLC method”. Pakistan Journal of Pharmaceutical Sciences 4 (2008): 421-425.
14. Jain D., et al. “Simultaneous estimation of metformin hydrochloride, pioglitazone hydrochloride, and GLM by RP-HPLC in tablet formulation”. Journal of Chromatographic Science 46 (2008): 501-504.
15. Chakradhar L., et al. “A rapid and highly sensitive method for the determination of GLM in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry: Application to a pre-clinical pharmacokinetic study”. Biomedical Chromatography 22 (2008): 58-63.
16. ICH Harmonized Tripartite Guideline, Validation of Analytical Procedures Text and Methodology, Q2 (R1)., Current Step 4 Version, Parent Guidelines on Methodology Dated November 6, 1996, Incorporated in November (2005).

Citation

Citation: Paladugu Venkata Naveen and Seru Ganapaty. “Development and Validation of LC-MS/MS method for Simultaneous Determination of Rosiglitazone and Glimepiride in Rat Plasma and its Application to Pharmacokinetic Studies". Acta Scientific Pharmaceutical Sciences 5.11 (2020): 33-41.

Copyright

Copyright: © 2020 Paladugu Venkata Naveen and Seru Ganapaty. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.