Abstract :
To determine Carisoprodol in bulk and pharmaceutical formulation an accurate, simple, precise rapid and
reproducible reverse phase HPLC method was developed and validated. The quantification was accomplished using
Genesis C18 (100x4.5mm; 4μm in particle size) column run in isocratic mode using mobile phase comprising of
Acetonitrile and 1.00% triethylamine (TEA) in water, pH altered to 3.50 with orthophosphoric acid (10% v/v) in
ratio of 35:65 v/v and a wavelength of 194nm was used for detection. 50.00µl was injected at 1.00ml/min(flow rate).
The retention time (RT) of Carisoprodol was established at 6.96±0.12 (n=6). The method was validated in terms of
linearity, accuracy precision, robustness, LOQ and LOD(ICH guidelines). 5.00µg/ml to 500.00µg/mL was the
linearity range of the present method with a correlation coefficient of r
2 = 0.9968. An average recovery of
100.65±0.11% was achieved. The LOQ and LOD was 1.26µg/mL and 0.41µg/mL respectively. The method was
found to be applicable for assay, stability studies and dissolution of marketed Carisoprodol tablet formulation. Tablet
assay using the present method was 100.72±0.63%. The % RSD from reproducibility was 0.43%. The present method
is applicable for routine quality control analysis (QC) of Carisoprodol in bulk and in pharmaceutical formulations.
Keyword :
Carisoprodol, RP-HPLC, Genesis C18, Validation.