RELIABLE SPECTROSCOPIC ANALYTICAL PROCEDURE FOR QUANTITATIVE ESTIMATION OF OSIMERTINIB MESYLATE IN LIPOSOMAL DRY POWDER INHALER FORMULATION

Objective: The objective of the present study was to develop an economical UV spectrophotometric method with a simple, rapid, accurate, precise, sensitive, and reproducible for quantitative estimation Osimertinib Mesylate (OM) in bulk newly prepared Liposomal Dry Powder Inhaler (LDPI) formulation which has not been reported earlier. Methods: Different dilutions were methanol range 4-16 µg/ml, scanned between 400-200 nm, determined maximum absorbance confirm drug’s λmax. Linearity, accuracy, precision, limit detection (LOD), quantitation (LOQ) used as parameters validate method. concentration OM calculated based on linear regression equation calibration curve. Results: spectrum showed λmax at 267 nm curve coefficient (R2) more than 0.997. RSD recovery studies found ˂ 2 % confirmed accuracy proposed LOD LOQ observed 0.021 µg/ml 0.063 respectively 0.056 0.170 LDPI formulation. be precise %. Conclusion: can successfully estimate LDPI, there is no interference excipients during study. validated compliance International Conference Harmonization (ICH) guidelines it should routine quality control analysis i.e., assay such dosage forms.