A Novel RP-HPLC Method Development and Validation of Mobocertinib in Capsule Dosage Form

Gobalakrishnan P*, V. Munisekhar, V. Hemanth Kumar
Volume-12, Issue-1, January 2024, 4632 | Full article PDF
https://doi.org/10.30904/j.ajcpr.2024.4632
Available online: Jan 25, 2024

A  B  S  T  R A C T
To develop a precise, linear, specific & suitable stability indicating RP-HPLC method for analysis of Mobocertinib, different chromatographic conditions were applied & the results observed are presented in previous chapters. Isocratic elution is simple, requires only one pump & flat baseline separation for easy and reproducible results. So, it was preferred for the current study over gradient elution. In case of RP-HPLC various columns are available, but here Develosil ODS HG-5 RP C₁₈, 5mm, 15cmx4.6mm column was preferred because using this column peak shape, resolution and absorbance were good. Mobile phase & diluent for preparation of various samples were finalized after studying the solubility of API in different solvents of our disposal (methanol, acetonitrile, dichloromethane, water, 0.1N NaOH, 0.1NHCl). The drug was found to be highly soluble in acetonitrile & dichloromethane and soluble in methanol. Drug was soluble in water. Using these solvents with appropriate composition newer methods can be developed and validated. Detection wavelength was selected after scanning the standard solution of drug over 200 to 400nm. From the U.V spectrum of Mobocertinib it is evident that most of the HPLC work can be accomplished in the wavelength range of 200-250 nm conveniently. Further, a flow rate of 1 ml/min & an injection volume of 20 µl were found to be the best analysis. The result shows the developed method is yet another suitable method for assay which can help in the analysis of Mobocertinib in different formulations.
Keywords: Mobocertinib, Develosil ODS HG-5 RP C18, Chromatography, HCl, NaOH, RP-HPLC