DEVELOPMENT AND VALIDATION OF RP- HPLC SIMULTANEOUS ESTIMATION METHOD OF MONTELUKAST AND BAMBUTEROL FOR STABILITY INDICATING ASSAY

Abstract

The objective of the current study was to develop and validate a simple, accurate, precise and selective stability-indicating 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.

Keywords: RP-HPLC, Validation, Stability-indicating assay, Montelukast, Bambuterol, Tablet.