Development and Validation of Spectroscopic Method for Simultaneous Estimation of Acebrophylline and Montelukast Sodium in Combined Dosage Form
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2012, Vol 2, Issue 4
Abstract
A novel combination of Acebrophylline and Montelukast Sodium is used in the treatment of chronic obstructive pulmonary disease (COPD) and bronchial asthma. A simple, sensitive, accurate and reproducible spectroscopic method has been developed and validated for the simultaneous estimation of Acebrophylline and Montelukast Sodium by solving of simultaneous equations (Vierodt's method). Acebrophylline and Montelukast Sodium were found to have absorbance maxima at 313 and 344.5 nm respectively in methanol. The method obeys Beer’s law in the concentration range of 20-140 μg/ml (R2 = 0.9997) for Acebrophylline and 1-7 μg/ml (R2 = 0.9993) for Montelukast sodium. The LOD and LOQ were found to be 2.46μg/ml and 7.45μg/ml for Acebrophylline and 0.22μg/ml and 0.68μg/ml for Montelukast Sodium respectively. The recovery of Acebrophylline and Montelukast Sodium were found to be 99.57% and 100.78% respectively showing accuracy of the method. The assay of marketed tablet formulation (Abrofyl-M) was found to be 99.41% and 102.26% for Acebrophylline and Montelukast Sodium respectively. The method was validated statistically as per ICH guidelines. The method showed good reproducibility and recovery with % RSD less than 2. So, the proposed method was found to be simple, specific, precise, accuracy, linear, and robust. Hence it can be applied for routine analysis of Acebrophylline and Montelukast Sodium in pharmaceutical formulations.
Authors and Affiliations
Jignesh Maniya, Hasumati Raj, Hasmukh Vaghani, Manoj Mangukiya, Pradip Dudhat
Keywords
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