Thursday , 29 February 2024

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

Gobala Krishnan P*, Munisekhar V, Ranjit Singh B. Rathore
Department of Pharmaceutical Chemistry, Vagdevi college of Pharmacy & Research centre, Nellore, Andhra Pradesh, India.

The chromatographic conditions were successfully developed for the separation of Erlotinib hydrochloride by using the HPLC method for Erlotinib hydrochloride as per ICH Guide lines. Shimadzu LC-2010 series with UV Detector and ACE 3 C18 (150×4.6mm, 3µ) column, injection of 10 µl is injected and eluted with the Preparation of mobile phase A: Mixed well about 930 mL of purified water, 70 mL of tetrahydrofuran and 1.5 mL of Trifluroacetic acid. And Preparation of mobile phase-B: Mixed well about 450 mL of purified water, 480 mL of acetonitrile, 70 mL of tetrahydrofuran and 1.5 mL of Trifluroacetic acid in the ratio 65:35, which was pumped at a flow rate of 1.5 ml at 245 nm. The peak of Erlotinib Hydrochloride was found well separated at 6.1 min. The developed method was validated for various parameters as per ICH guidelines like system suitability, linearity, rang, accuracy, precision, specificity, ruggedness, and robustness. UV- spectroscopy (made- Shimadzu) was used with mobilphse-A and mobile phase-B in the ratio 65:35, which was detected at single point 245 nm. The absorbance of Erlotinib Hydrochloride was found. The analytical method validation of Erlotinib Hydrochloride by RP-HPLC method was found to be satisfactory and could be used for the routine pharmaceutical analysis of Erlotinib Hydrochloride.
Keywords: Erlotinib hydrochloride, HPLC, Rang, Accuracy, Precision, Specificity, Ruggedness

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