Abstract
The aim of the proposed research work was to develop and validate a simple, selective high sensitive and high-throughput assay for the simultaneous estimation of Atorvastatin and Glimepiride in human plasma using liquid chromatography tandem mass spectrometry (LC-MS/MS). Atorvastatin–Glimepiride combines a competitive inhibitor of HMG-CoA reductase and a sulfonylurea anti-diabetic drug. The purpose of this study was to develop single method for Atorvastatin and Glimepiride in plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) that would result into a simultaneous estimation of Atorvastatin and Glimepiride avoiding acid –lactone inter conversions right from sample collections to analysis on the LC-MS/MS. Sample collection procedure optimized for Atorvastatin holds good for Glimepiride, hence resulting into a simultaneous estimation of Atorvastatin and Glimepiride. Liquid-liquid extraction and liquid chromatography coupled to positive ion mode tandem mass spectrometry was used to develop the method and was validated according to US FDA guidelines. The calibration curves for two analytes were linear (R2 ≥ 0.9950, n = 4) over the concentration range of 0.2 - 30 ng/mL for Atorvastatin and 1 - 250 ng/mL for Glimepiride. Mean extraction recoveries 80.34 ± 9.43 for Atorvastatin and 88.19 ± 7.13 for Glimepiride. Intra- and inter-run mean percent accuracy was between 85% - 115% and percent imprecision was ≤15%. Stability studies revealed that Atorvastatin and Glimepiride were stable in plasma during bench top (10.5 h at room temperature), in Injector (47.5 h), at the end of three successive freeze and thaw cycles and long term at -65℃ ± 15℃ for 114 days. The method was successfully applied to the study of pharmacokinetics of Atorvastatin and Glimepiride in healthy volunteers. Simultaneous estimation of Atorvastatin and Glimepiride is cost effective, reduces analysis cycle time, enables effective utilization of resources and reduces bleeding burden on human volunteers.
Highlights
Atorvastatin (ATV) is (3R,5R)-7-[2-(4-fluorophenyl)-3phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol1-yl]-3,5-dihydroxyheptanoic acid [CAS no: 134523-038] (Figure 1)
The purpose of this study was to develop single method for Atorvastatin and Glimepiride in plasma by liquid chromatography-tandem mass spectrometry (LC-MS/MS) that would result into a simultaneous estimation of Atorvastatin and Glimepiride avoiding acid-lactone inter conversions right from sample collections to analysis on the LC-MS/MS
Sample collection procedure optimized for Atorvastatin holds good for Glimepiride, resulting into a simultaneous estimation of Atorvastatin and Glimepiride
Summary
Atorvastatin (ATV) is (3R,5R)-7-[2-(4-fluorophenyl)-3phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol1-yl]-3,5-dihydroxyheptanoic acid [CAS no: 134523-038] (Figure 1). It is a HMG-CoA (3-hydroxy-3-methylglutaryl-coenzymeA) reductase inhibitor. GLI (CAS no: 93479-97-1; Figure 1) is a medium-to-long acting sulfonylurea anti-diabetic drug. GLI acts as a secretagogue [3] It lowers blood sugar by stimulating the release of insulin by pancreatic beta cells and by inducing increased activity of intracellular insulin receptors. Atorvastatin (ATV)-Glimepiride (GLI) combines a competitive inhibitor of HMGCoA reductase and a sulfonylurea anti-diabetic drug GLI. In the references few bioanalytical methods were reported for the determination of ATV and GLI separately and in combination with another products [4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21]. Harshini et al (2011) reported a method for simultaneous determination
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
