Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 6, July 2007, pp.311-314
Development and Validation of a Selective Online
Dissolution Method for Rosiglitazone Maleate
Saleem Shaikh[1], M.S. Muneera[1], O.A. Thusleem[1],
Muhammad Tahir[1], Anand V. Kondaguli[1], and K. Ruckmani[2]
[1]Department of Analytical Research & Development, Jamjoom
Pharmaceuticals, P.O. Box 6267, Jeddah-21442, Saudi Arabia and
[2]Department of Pharmaceutical Engineering and Technology, Bharathidasan
University, Trichy-24
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 µg/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.
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