HPLC method for the determination of rosiglitazone in human plasma and its application in a clinical pharmacokinetic study.
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.
Drug Metabolism and Pharmacokinetics Laboratory, Department of Preclinical Biology, Dr. Reddy's Research Foundation, Hyderabad, India.
Rao N V S
RN
Mamidi
Madhusudana R
MR
Chaluvadi
Biju
B
Benjamin
Mullangi
M
Ramesh
Kasiram
K
Katneni
Aravinda P
AP
Babu
Jaydip
J
Bhanduri
Naidu M U
NM
Rao
Ramanujam
R
Rajagopalan
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D007004:Hypoglycemic Agents / Q000097:blood* / Q000493:pharmacokinetics*; D008297:Male; D012015:Reference Standards; D015203:Reproducibility of Results; D000077154:Rosiglitazone; D013050:Spectrometry, Fluorescence; D013844:Thiazoles / Q000097:blood* / Q000493:pharmacokinetics*; D045162:Thiazolidinediones
D007004:Hypoglycemic Agents; D013844:Thiazoles; D045162:Thiazolidinediones; D000077154:Rosiglitazone