ABSTRACT
A high-pressure liquid chromatography [HPLC-UV] based simple and specific method for simultaneous quantitative determination of Ofloxacin, Fexofenadine HCl and Diclofenac Potassium has been developed and validated according to ICH guidelines. Chromatographic separation of the three drugs was carried out on 4.6 x 250mm x 5micro Licrospher RP Select B Column, using mobile phase constituted of methanol and phosphate buffer pH 3.5 [650: 350], pH adjusted to 3.5 +/- 0.05 with dilute ortho-phosphoric acid and delivered at a flow rate of 1ml/min. The eluents were detected at UV wavelength of 220nm and the retention times for Ofloxacin, Fexofenadine HCl and Diclofenac Potassium were 2.5 minutes, 4 minutes and 11.5 minutes, respectively. This method is suitable and specific for the three drugs and was found to be linear [R2>0.996], accurate, specific, reproducible and robust over a concentration range of 0.05 to 0.15mg/ml for Ofloxacin, 0.015 to 0.045mg/ml for Fexofenadine HCl and 0.0125 to 0.0375mg/ml for Diclofenac Potassium. The proposed method is simple and convenient, hence easily utilized for the characterization and quantitation of the three drugs in a single formulation for combination therapy of rheumatoid arthritis, sepsis, infection with fever and flu
ABSTRACT
A high-pressure liquid chromatography [HPLC-UV] based simple and specific method for simultaneous quantitative determination of aspirin, amlodipine besylate and simvastatin in a capsule formulation has been developed and validated according to ICH guidelines
Chromatographic separation of the three drugs was carried out by aSpherisorbODS2 reverse phase column [4.6 x 250 mm; 5 microm] using amobile phase, which consisted of 70: 30 [v/v] mixture of acetonitrile and triethylamine phosphate buffer [pH 3; 0.015 M] with final pH adjusted to 2.5 using dilute ortho-phosphoric acid, at a flow rate of ImL/min. The eluents were detected at UV wavelength of 237 nm and the retention times for aspirin, amlodipine besylate and simvastatin were -2.7 mins, -6.1 mins and 10.5mins, respectively. This method is suitable and specific for the three drugs and was found to be linear [R[2]>0.995], accurate, specific, reproducible and robust in the concentration range of 375 to 1125mcg/ml for aspirin, 25 to 75mcg/ml for amlodipine besylate and 50 to 150mcg/ml for simvastatin. This simple and convenient method could be easily utilized for the characterization and quantitation of the three drugs in a single formulation for combination therapy of cardiovascular diseases