Analytical Method Development and Validation for Rabeprazole and Domperidone in Combine Dosage Form by RP-HPLC

Dr. Gampa Vijay Kumar^1*, C. Yamuna^2
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.

A B S T R A C T
A new method was established for simultaneous estimation of   Rabeprazole and  Domperidone  by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of  Rabeprazole and  Domperidone  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 2.170 mins and 7.025 mins. The % purity of  Rabeprazole and  Domperidone  was found to be 99.1% and 98.2% respectively. The system suitability parameters for  Rabeprazole and  Domperidone  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  Rabeprazole and  Domperidone  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: Rabeprazole and Domperidone , C18 column, RP-HPLC