Abstract A simple, fast, accurate and precise reverse phase high performance liquid chromatographic method has been developed for the estimation of Griseofulvin in oral suspension. The chromatographic separation was achieved on Zorbax eclipse plus C8 (250 x 4.6) mm; 5µm particle size column with a gradient mixture of mobile phase containing acetonitrile: ortho-phosphoric acid buffer: methanol (10:50:40 v/v). The injection volume was kept at 20 μl with mobile phase at a flow rate of 1.5 ml/min. The wavelength of detection was kept at 254 nm with column temperature at 25 ºC. The selected chromatographic conditions were found effectively to separate Griseofulvin at 12.84 min with its excipients methylhydroxy benzoate at 4.192 min and propylhydroxy benzoate at 11.021 min. The linearity was obtained in range of 125-1250 μg/ml for Griseofulvin, 7.5-75.01 μg/ml for methylhydroxy benzoate and 0.5-5.01 μg/ml for propylhydroxy benzoate with correlation coefficient 0.999, 0.999 and 0.999 for GRS, methylhydroxy benzoate and propylhydroxy benzoate, respectively. The proposed methods were validated as per ICH guidelines and successfully applied for the determination of investigated drugs in oral suspension.
Keywords Griseofulvin, oral suspension, RP-HPLC, methylhydroxy benzoate, propylhydroxy benzoate