title: Novel liquid chromatographic method for simultaneous estimation of pioglitazone and glimepiride in rat plasma by solid phase extraction: application to preclinical pharmacokinetic studies.
abstract: The need for a reliable bioanalytical method is of primary importance during preclinical studies. The aim of the present study was simultaneous determination of pioglitazone (CAS 111025-46-8) (PIO) and glimepiride (CAS 93479-97-1) (GLM) in plasma of rats. A high-performance liquid chromatographic method has been developed and validated using C18 column and UV detector. A mobile phase composed of acetonitrile and ammonium acetate buffer pH 4.5 in the ratio of 55:45%. The plasma samples clean-up was carried out using solid phase cartridges. The method was in the linear range of 50-8000 ng/mL for PIO and 50-2000 ng/mL for GLM. The coefficient of regression was found to be > or = 0.99. Precision and accuracy were within the acceptable limits, as indicated by relative standard deviation varying from 1.5 to 6.1% for PIO and 3.1 to 7.0% for GLM whereas the accuracy ranged from 97.0 to 106.4% for PIO and 96.5 to 106.4% for GLM. The mean extraction recovery was found to be 90.2 +/- 4.5, 76.8 +/- 2.8 and 85.2 +/- 5.2% for PIO, GLM and internal standard, respectively. Moreover, PIO and GLM were stable in plasma, up to 30 days of storage at -70 degrees C and after being subjected to bench top, auto-sampler, and three freeze-thaw cycles. The developed method was applied for preclinical pharmacokinetic studies.
authors.affiliation: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, India. prashant.pqa@manipal.edu
authors.forename: Prashant B
authors.initials: PB
authors.lastname: Musmade
authors.forename: Kranti B
authors.initials: KB
authors.lastname: Talole
authors.forename: Praful B
authors.initials: PB
authors.lastname: Deshpande
authors.forename: Arumugam
authors.initials: A
authors.lastname: Karthik
authors.forename: Shriram M
authors.initials: SM
authors.lastname: Pathak
authors.forename: Sureshwar
authors.initials: S
authors.lastname: Pandey
authors.forename: Nayanabhirama
authors.initials: N
authors.lastname: Udupa
mesh_terms: D000818:Animals; D019540:Area Under Curve; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004347:Drug Interactions; D006207:Half-Life; D007004:Hypoglycemic Agents / Q000097:blood* / Q000493:pharmacokinetics*; D008297:Male; D000077205:Pioglitazone; D051381:Rats; D017208:Rats, Wistar; D012015:Reference Standards; D015203:Reproducibility of Results; D052616:Solid Phase Extraction; D013056:Spectrophotometry, Ultraviolet; D013453:Sulfonylurea Compounds / Q000097:blood* / Q000493:pharmacokinetics*; D045162:Thiazolidinediones / Q000097:blood* / Q000493:pharmacokinetics*
chemical_list: D007004:Hypoglycemic Agents; D013453:Sulfonylurea Compounds; D045162:Thiazolidinediones; C057619:glimepiride; D000077205:Pioglitazone