Wednesday , 19 June 2024

Analytical Method Development and Validation for the Estimation of Pantoprazole by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

Y. Krishna Reddy*, D. Ramesh, D. Kowshik, E. Manisha, K. Manisha, G. Kiranmayi   
Bomma Institute of Pharmacy, Khammam, Telangana, India

The chromatographic conditions were successfully developed for the separation of Pantoprazole by using thermosil C18 4.5×150 mm 5.0 µm, flow rate was 0.8ml/min, mobile phase ratio was 65:35% v/v methanol:water, detection wavelength was 265nm. The instrument  used  was  WATERS HPLC  Auto Sampler, Separation module 2695, photo diode array detector 996, Empower-software version-2. The retention times were found to be 4.35 mins. The % purity of Pantaprazole was found to be 99.87%. The system suitability parameters for Pantaprazole such as theoretical plates and tailing factor were found to be4146, 1.23, the resolution was found to be 5.67. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Pantaprazole was found in concentration range of 30µg-150µg and correlation coefficient (r2) was found to be 0.999, % recovery was found to be 100.4%, %RSD for repeatability was 0.5, % RSD for intermediate precision was 1.0. The precision study was precision, robustness and repeatabilty.LOD value was 2.97 and LOQ value was 9.92.Hence the suggested RP-HPLC method can be used for routine analysis of Pantaprazole in API and Pharmaceutical dosage form.
Keywords: Pantoprazole, HPLC, LOD, LOQ

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