Analytical Method Development and Validation for the Estimation of Combined Antineoplastic Agents by RP-HPLC

Jhansi Rani Sriramula; Shivaraj Shivaraj

doi:10.47957/ijpda.v13i3.632

Authors

Jhansi Rani Sriramula Research Scholar, University College of Technology, Osmania University, Hyderabad-500007, Telangana State, India
Shivaraj Professor & Principal, University College of Science and Bos Chemistry, Osmania University Hyderabad-500007, Telangana State, India

DOI:

https://doi.org/10.47957/ijpda.v13i3.632

Keywords:

Encorafenib, Cetuximab, Method development, Validation

Abstract

A rapid and reliable RP-HPLC method was developed and validated for the simultaneous quantification of Encorafenib and Cetuximab in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved using a Waters X-Terra RP-18 column with a mobile phase of Acetonitrile and 0.1% TEA buffer (pH 2.5) in a 40:60 ratio, at a flow rate of 1.0 mL/min, and detection at 240 nm. The method was validated as per ICH guidelines for system suitability, specificity, linearity, accuracy, precision, robustness, and stability-indicating capability. Linearity was observed over a range of 18.75–112.50 µg/mL for Encorafenib and 1.25–7.50 µg/mL for Cetuximab. Recovery values were within acceptable limits, and %RSD was consistently below 2%, indicating good accuracy and precision. Forced degradation studies under acidic, basic, oxidative, photolytic, and thermal conditions confirmed the method’s specificity and stability-indicating nature. The method proved to be robust under minor variations in flow rate and mobile phase composition. Overall, the developed method is simple, accurate, and suitable for routine quality control and stability studies of Encorafenib and Cetuximab in combined formulations

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