Журнал хроматографии и методов разделения
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Validated Chromatographic Methods for Determination of Pioglitazone and Glimepiride in Pharmaceutical Dosage Form and in Human Plasma

Safaa M. Riad, Miriam Farid, Mona H.Abdel Rahman, Dina Atef

Two simple, sensitive and selective chromatographic methods were described for simultaneous determination of Pioglitazone (PGZ) and Glimepiride (GLM) in their tablet formulation and in human plasma. The first method Thin Layer Chromatography (TLC) was performed on aluminium TLC plates pre coated with silica gel 60 F254 as the stationary phase and a mixture of Toluene: Methanol: Ethyl acetate as the mobile phase by ratio 6:2:4, v/v/v to give compact spots for PGZ at Rf=0.88 and GLM at Rf=0.63 with linearity range and mean percentage recoveries 0.5-5 μg spot-1, 99.00% for PGZ and 0.7-2 μg spot-1, 99.97% for GLM and the chromatogram was scanned at 266 nm. The second method High Performance Liquid Chromatography (HPLC) was developed for determination of the co-administered drug Duloxetine (DUL) with the drugs of interest (PGZ and GLM). Using Xterra C18 column and gradient mobile phase consisting of acetonitrile: water at pH 2.5 adjusted by orthophosphoric acid by ratio (30:70) from 0:10 minutes, then 10:15 minutes by ratio (85:15), respectively with flow rate 1.5 ml/min for the separation of PGZ (tR=1.1), GLM (tR=8.1) and DUL as co-administered drug (tR=2.2). Quantitation was achieved with UV detection at 220 nm. The linearity range was (2:50 μg/ml) for the three drugs and the mean percentage recoveries were found to be 100.26%, 99.53% and 99.89% for PGZ, GLM and DUL, respectively. Both methods were optimized and validated as per ICH guidelines.