Development and validation of a selective online dissolution method for rosiglitazone maleate.
A new specific, accurate, precise, and reproducible selective online dissolution method for rosiglitazone maleate is developed and validated for the dissolution of rosiglitazone maleate in pharmaceutical formulations. The rationale of the method is based on the direct measurement of the absorbance of the analyte in the buffer medium at 242 nm using buffer as blank. Dissolution is achieved on a dissolution test apparatus consisting of photo diode array spectrophotometer, peristaltic pump, and temperature controller, using 0.01N HCl and 0.05M potassium chloride as the dissolution medium. The proposed method is developed, optimized, and validated in terms of linearity, reproducibility, accuracy, and selectivity for the dissolution of rosiglitazone maleate in pharmaceutical formulations. The method is found to be linear in the range of 1 to 14 microg/mL of rosiglitazone maleate with a correlation coefficient of 0.999. The dissolution studies of rosiglitazone maleate tablets obtained by the proposed method are in good agreement with those by high-performance liquid chromatography.
Shaikh
Saleem
S
Department of Analytical Research & Development, Jamjoom Pharmaceuticals, P.O. Box 6267, Jeddah-21442, Saudi Arabia. saleem@jamjoompharma.com
Muneera
M S
MS
Thusleem
O A
OA
Tahir
Muhammad
M
Kondaguli
Anand V
AV
Ruckmani
K
K
D002138:Calibration; D007004:Hypoglycemic Agents / Q000032:analysis*; D000077154:Rosiglitazone; D012995:Solubility; D045162:Thiazolidinediones / Q000032:analysis*
D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone