ABSTRACT

Montelukast sodium and Acebrophylline tablets, an oral combination, is used to treat asthma. The present work comprises developing and validating a RP-HPLC method for the estimation of Montelukast sodium and Acebrophylline simultaneously, in bulk and marketed dosage form. This simple method was found to be sensitive, accurate and reproducible as well. Drugs were separated using C-18 column (5.0 ?, 4.6 X 250 mm) and Methanol: Phosphate Buffer (85:15) + GAA5% (PH3.5) was used as a mobile phase. Montelukast and Acebrophylline were eluted at respective retention times (RT) of 3.3 and 4.5 min and detected at 245 nm. For Montelukast and Acebrophylline, the linearity ranges were 4–20 ?g/ml and 80–400 ?g/ml respectively. The method was validated as per ICH guidelines and applied for estimation of Montelukast sodium/Acebrophylline in tablets with no interference of the excipient peaks. Thus, it can be successfully applied to the aforementioned drugs in bulk or combination dosage forms during quality control analysis. Keywords: Acebrophylline, Montelukast Sodium, RP-HPLC, Simultaneous estimation, Validation
Publication date: 01/10/2024

https://ijbpas.com/pdf/2024/October/MS_IJBPAS_2024_8388.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.10.8388