Abstract
ASSAY METHOD DEVELOPMENT AND VALIDATION FOR S IMULTANEOUS ESTIMATION OF PAROXETINE AND CLONAZEPAM BY RP- HPLC

Pattan Shahina Sulthana*, D. Dhachinamoorhti and Ch. M. M. Prasada Rao

ABSTRACT

A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Paroxetine and Clonazepam in pharmaceutical dosage form. Chromatographic separation was performed on INERTSIL ODS 3V column, C18(250x4.6 ID) column, with mobile phase comprising of mixture of buffer (pH7, adjusted with ammonium acetate), methanol, acetonitrile in the ratio of 3:2:5, at the flow rate 1.0 ml/min. The detection was carried out at 224 nm. The retention times of paroxetine and clonazepam were found to be 2.367 and 4.867 mins respectively with a run time of 6 mins, theoretical levels for paroxetine and clonazepam were 2320 and 3211 respectively, with a resolution of 8.249. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of paroxetine was found in the range of 60-140μg/mL and that for clonazepam was found to be 2.4-5.6μg/mL.

Keywords: Paroxetine, Clonazepam, RP-HPLC, Method development, Validation.


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