DEVELOPMENT AND VALIDATION OF RP- HPLC SIMULTANEOUS ESTIMATION METHOD OF MONTELUKAST AND BAMBUTEROL FOR STABILITY INDICATING ASSAY
Journal Title: Journal of Drug Discovery and Therapeutics - Year 2013, Vol 1, Issue 9
Abstract
The objective of the current study was to develop and validate a simple, accurate, precise and selective stabilityindicating gradient reverse phase high performance liquid chromatographic method for simultaneous estimation of Montelukast (MTK) and Bambuterol (BBL) in pharmaceutical formulation in presence of degradation products. The chromatographic separation of MTK and BBL was achieved on Shimadzu LC-20AT series HPLC having C18- ODS bonded column (250 ×4.6 mm, 40 °C, 10 μL) using UV/Visible detector at 231 nm. The optimized mobile phase was consisted of a acetonitrile (100%) at a flow rate of 1.5 mL/min. The retention times were 4.65 and 2.69 min for bambuterol and montelukast respectively. The proposed method provided linear responses within the concentration ranges 0-50μg/mL for bambuterol and montelukast. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.0259, 0.078 μg/mL and 0.0206, 0.062 μg/mL for bambuterol and montelukast, respectively. The developed method was validated as per ICH guidelines with respect to specificity, linearity, accuracy, precision, robustness and ruggedness. The studies data revealed that developed method was convenient, fairly reliable, sensitive, less expensive and reproducible.
Authors and Affiliations
Ashish Kumar Jain*| Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India., Nivrati Jain| Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India., Harshita Jain| Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India., Prateek Kumar Jain| Adina Institute of Pharmaceutical Sciences, Sagar, 470002, (M.P), India.
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