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VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF TRAZODONE HYDROCHLORIDE IN MARKETED FORMULATION
Rama Rai*, Mrs. Shweta Gogate, Pushpendra Soni, Lavakesh Kumar Omray
Radharaman Institute of Pharmaceutical Sciences, Bhopal
The present paper deals with the development of a rapid and feasible reveres phase high-performance liquid chromatographic method for the determination of trazodone in bulk and pharmaceutical dosage form. Chromatographic separation achieved isocratically on thermo C18 column (5 μm, 150mm x 4.60mm) and acetonitrile: methanol in the ratio of 50:50 (v/v) as the mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 256 nm. The retention times for TRZ was found to be 3.53 ±0.5 min. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the ICH guidelines. The method was linear in the concentration range of 5-25 μg/ml with correlation coefficient of 0.999. The mean recoveries obtained for TRZ 99.78 % and RSD was less than 2. The correlation coefficients for all components are close to 1. Developed method was found to be accurate, precise, selective and rapid for estimation of TRZ.
Keywords: RP-HPLC, trazodone, Method development, Validation
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