Saturday , 4 December 2021

RP-HPLC Method Development and Validation for Simultaneous Estimation of Paroxetine and Clonazepam in Its Active Pharmaceutical Ingredient and Pharmaceutical Dosage Forms

Dr. Gampa Vijay Kumar1, Dr. T Rjesh2, T. Sai priya3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India

ABSTRACT
A new method was established for simultaneous estimation of Paroxetine and Clonazepam by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Paroxetine and Clonazepam by using Zodiac sil C18 column (4.6×150mm)5µ, flow rate was 1ml/min, mobile phase ratio was (70:30 v/v) methanol: phosphate buffer(KH2PO4and K2HPO4) phosphate pH 3 ( pH was adjusted with orthophosphoricacid), detection wavelength was 240nm. The instrument used was Shimadzu, model No. SPD-20MA LC+20AD, Software- LC-20 Solution. The retention times were found to be 2.170mins and 7.025mins. The % purity of Paroxetine and Clonazepam was found to be 99.98% and 98.87% respectively. The system suitability parameters for Paroxetine and Clonazepam such as theoretical plates and tailing factor were found to be 12294, 1.27 and 10491 and 1.03, the resolution was found to be 8.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of  Paroxetine and Clonazepam was found in concentration range of 16µg-80µg and 25µg-125µg and correlation coefficient (r2) was found to be 0.999 and 0.998, % recovery was found to be 101.7% and 102.0%, %RSD for repeatability was 0.8and 0.5, % RSD for intermediate precision was 1.99 and 1.82 respectively. The precision study was precision, robustness and repeatabilty. LOD value was 2.17 and 0.0372 and LOQ value was 6.60 and 0.1125 respectively.
Keywords: Paroxetine and Clonazepam, C18 column, RP-HPLC

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