Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 5 Issue 11

Development and Validation of LC-MS/MS method for Simultaneous Determination of Rosiglitazone and Glimepiride in Rat Plasma and its Application to Pharmacokinetic Studies

Paladugu Venkata Naveen* and Seru Ganapaty

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh, India

*Corresponding Author: Paladugu Venkata Naveen, Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra Pradesh, India.

Received: August 18, 2021; Published: October 19, 2021

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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

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References

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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.




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