HPLC method for the determination of rosiglitazone in human plasma and its application in a clinical pharmacokinetic study |
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Authors: | Mamidi Rao N V S Chaluvadi Madhusudana R Benjamin Biju Ramesh Mullangi Katneni Kasiram Babu Aravinda P Bhanduri Jaydip Rao Naidu M U Rajagopalan Ramanujam |
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Affiliation: | Drug Metabolism and Pharmacokinetics Laboratory, Department of Preclinical Biology, Dr. Reddy's Research Foundation, Hyderabad, India. |
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Abstract: | Rosiglitazone (CAS 155141-29-0, Avandia) is a novel insulin sensitizer used in the treatment of type 2 diabetes. A sensitive high performance liquid chromatography (HPLC) method for its determination in human plasma using fluorescence detection (excitation: 247 nm, emission: 367 nm) with a suitable internal standard (I. S.) is described. Ethyl acetate was used as extraction solvent. A mobile phase consisting of phosphate buffer, acetonitrile and methanol was used at a flow rate of 1.0 ml/min on a C18 column. The absolute recovery was > 90% and the lower limit of quantitation was 5 ng/ml. The intra- and inter-day relative standard deviations ranged from 0.58-6.69% and 0.82-6.63%, respectively. The method described is simple, economical, precise and accurate and has been successfully applied in a pharmacokinetic study conducted in healthy human volunteers. |
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