ASSAY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PAROXETINE AND CLONAZEPAM BY RP- HPLC
Journal Title: Int J of Preclin & Pharm Res - Year 2014, Vol 4, Issue 8
Abstract
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 Agilent Eclipse XDB (C8) (4.6mm x 150mm, 5m) column, with mobile phase comprising of mixture of buffer (pH7, adjusted with ammonium acetate), acetonitrile in the ratio of 82:18v/v, at the flow rate 0.8 ml/min. The detection was carried out at 265 nm. The retention times of paroxetine and clonazepam were found to be 2.36 and 3.14 mins respectively with a run time of 5 mins, theoretical levels for paroxetine and clonazepam were 6753 and 4693 respectively, with a resolution of 5.10. 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 100-300µg/mL and that for clonazepam was found to be 2-6 µg/mL. Keywords: Paroxetine, Clonazepam, RP-HPLC, Method development, Validation.
Authors and Affiliations
Bhagyasree T* , Neelam I , Ajitha A , Uma Maheshwara Rao V
Keywords
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