Development and validation of a RP-UPLC method for the determination of betamethasone dipropionate impurities in topical formulations using a multivariate central composite design
Siva Krishna Muchakayala, Kommera Pavithra, Naresh Kumar Katari, Vishnu Murthy Marisetti, Thirupathi Dongala, Raju V. K. Vegesna
Abstract
, 100 mm × 2.1 mm, 1.7 μm column with a gradient mode of elution comprising 20 mM phosphate buffer: ACN 70 : 30, v/v as mobile phase-A and 20 mM phosphate buffer: ACN 30 : 70, v/v as mobile phase-B. The developed method was validated in accordance with ICH guidelines. The validation data conclude that the developed method is specific, accurate, linear, precise, rugged, and robust for the quantification of impurities in BMD topical formulations.
Topics & Concepts
Betamethasone dipropionateChromatographyCentral composite designBetamethasoneChemistryQuality by DesignImpurityHigh-performance liquid chromatographyMultivariate statisticsMathematicsResponse surface methodologyMedicineOrganic chemistryInternal medicineStatisticsParticle sizePhysical chemistryAnalytical Methods in PharmaceuticalsAnalytical Chemistry and ChromatographyPesticide Residue Analysis and Safety