SIMULTANEOUS ESTIMATION OF GIMERACIL AND OTERACIL POTASSIUM BY RP-HPLC METHOD

Abstract

A simple,  precise,  reliable,  rapid  and  reproducible  reversed-phase  high  performance liquid chromatography method was developed and validated for the simultaneous estimation of Gimeracil  Maleate, Oteracil potassium Chromatography is carried out isocratically on X-bridge C18 (100 nm×4.6 nm×5µm)with a mobile phase composed of 0.1% Ortho Phosphoric Acid and Acetonitrile (in the ratio of 90:10 (v/v) at a flow rate of 0.9 ml/min. Detection was carried out using a PDA(2996) detector at  290 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH-Q2 (R1) guidelines. The retention times of Gimeracil (GEM) and Oteracil potassium (OTP) are 2.9, 6.9min respectively. The linearity range and % recoveries of Gimeracil and Oteracil potassium are 20-150μg/ml and 99%, 101% respectively. The correlation coefficients of ART and PQP are 0.999. The % relative standard deviations for three replicate  measurements in three concentrations of samples in tablets are always less than 2%. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of Gimeracil and Oteracil potassium in pharmaceutical dosage form. The proposed method can be useful in quality control of bulk Manufacturing and Pharmaceutical dosage forms.