High Pressure Liquid Chromatographic Method for the Determination of Mobocertinib in Pharmaceutical Dosage Form and Study of Its Degradation
Gunturu. Raviteja *
Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur-522019, Andhra Pradesh, India.
Kantipudi Rambabu
Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur-522019, Andhra Pradesh, India.
*Author to whom correspondence should be addressed.
Abstract
Aims: New validated method for the estimation of Mobocertinib using HPLC and study of its degradation.
Place and Duration of Study: Department of Chemistry, RVR & JC College of Engineering, Chowdavaram, Guntur, Andhra Pradesh, between February 2021 and August 2021.
Methodology: Using an X-bridge phenyl column (150 mm x 4.6 mm, 3.5 µ), acetonitrile, and 0.1 percent ortho phosphoric acid (OPA) (60:40 v/v) as a mobile phase, the proposed method successfully achieved effective chromatographic separation with a flow rate of 1 mL/min and a wave length of 224 nm. Mobocertinib had a retention time of 2.271 minutes. The isocratic chromatography was performed at room temperature and took approximately five minutes to complete.
Results: Analysis was achieved within 5 min over an honest linearity within the concentration range from 6-90 µg/ml of Mobocertinib. Using a mathematical process, the suitability parameters of the system were investigated, and the results were found to be in acceptable limits. In a linear analysis, stages with regression coefficients of 0.999 were used. LOD and LOQ values were 0.075μg/ml and 0.248 g/ml for Mobocertinib. The drug was recovered at a rate of 98-102 percent, which means that the recovery is within reasonable limits.
Conclusion: The validation results were satisfactory, and the approach was found to be suitable for bulk and formulation analysis. The recommended procedure was found to be warranted according to ICH guidelines.
Keywords: Mobocertinib, development, validation, RP-HPLC, degradation studies