ABSTRACT

Objective: The aim of this work is to develop and validate a simple, synchronous and novel UPLC method for stability indicating assay method to estimate Aclidinium bromide and formoterolfumarate in both bulk and its dosage form. Materials and Methods: This method is based on isocratic elution using HiberC18( 100x 2.1mm 1.8?) column with phosphatebuffer : Acetonitrile (60:40) mobile phase . Detection was monitored at 240nm with flow rate 0.3ml/min. Results: The method was validated in terms of linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ) etc. in accordance with ICH guidelines. The retention times of Aclidinium and formoterol are 1.09 and 1.39, respectively. Linear regression analysis data for the calibration plot showed that there was good linear relationship between response and concentration in the range for Aclidinium 100-600?g/ml and formoterol 3-18?g/ml. Conclusion: No chromatographic interference from dry powder inhaler’s excipients and degradants were found. The proposed method was successfully used for concurrent estimation of Aclidinium and formoterol in dry powder inhaler dosage form. Keywords: stability indicating, UPLC, Aclidinium andformoterol
Publication date: 01/02/2022

https://ijbpas.com/pdf/2022/February/MS_IJBPAS_2022_5886.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.2.5886