Newly Developed and Validated Method of Montelukast Sodium Estimation in Tablet Dosage Form by Ultraviolet Spectroscopy and Reverse Phase - High Performance Liquid Chromatography

Group View

Abstract
PTB Reports,2016,2,2,27-30.
Published:May 2016
Type:Original Article

Newly Developed and Validated Method of Montelukast Sodium Estimation in Tablet Dosage Form by Ultraviolet Spectroscopy and Reverse Phase - High Performance Liquid Chromatography

Selvadurai Muralidharan1*, Low Jia Qi1, Lai Ting Yi1, Narvinder Kaur1, Subramani Parasuraman2, Jayaraja kumar3, Vijayan Venugopal3, Palanimuthu Vasanth Raj3

1Unit of Pharmaceutical Chemistry, Faculty of Pharmacy, AIMST University, MALAYSIA.

2Unit of Pharmacology, Faculty of Pharmacy, AIMST University, MALAYSIA.

3Unit of Pharmaceutics, Faculty of Pharmacy, AIMST University, MALAYSIA.

Abstract:

Objective: Simple high performance liquid chromatographic (HPLC) and ultraviolet (UV) methods were newly developed and validated for the quantitative estimation of Montelukast (ML) in pharmaceutical dosage form. Material and Methods: HPLC was carried out by reverse phase-HPLC technique on a C18 column with a good mobile phase consist of 10 mM ammonium acetate and acetonitrile [(pH 5.5 adjusted with orthophosphoric acid (25:75, v/v)]. UV method was developed with the wavelength at 280 nm. Two methods showed good linearity, reproducibility and precision. Both the methods (UV and HPLC) showed no spectral or chromatographic interferences from the tablet excipients. Results: The developed methods were successfully applied to dosage forms. Validation parameters were carried out such as linearity, precision, accuracy, and specificity. The HPLC LOD and LOQ for montelukast were found to be 150 ng/ml and 500 ng/ml. The UV LOD and LOQ for montelukast were found to be 1 μg/ml and 5 μg/ ml. Both the results were statistically differentiated using one-way analysis of variance (ANOVA). The developed and validated economical methods could be applicable for analysis of ML and monitoring of the quality of available drugs.