Wednesday , 19 June 2024

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

Krishna Reddy*, K. Pranaya, K. Babu, MA. Tanjeema, N. Ravi kumar, Udayasri
Bomma Institute of Pharmacy, Khammam, Telangana, India

The chromatographic conditions were successfully developed for the separation of Ceritinib by using Kromosil C18 4.5×150 mm 5.0 µm, flow rate was 0.8ml/min, and 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 2.182 mins. The % purity of Ceritinib was found to be 99.87%. The system suitability parameters for Ceritinib 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 Ceritinib 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 Ceritinib in API and Pharmaceutical dosage form.
Keywords: Ceritinib, HPLC, LOD, LOQ

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