QUANTIFICATION OF BILASTINE AND MONTELUKAST COMBINATION IN FORMULATIONS UTILIZING LIQUID CHROMATOGRAPHY: STABILITY STUDIES

KANCHARLA VIJAYALAKSHMI; BETHAPUDI SAMUEL ANAND ANDREWS; BOLINENI NAGESWARA RAO

doi:10.22159/ijap.2021v13i6.41915

Authors

KANCHARLA VIJAYALAKSHMI Quality Control Department, Divis laboratories limited, Hyderabad, India 508252
BETHAPUDI SAMUEL ANAND ANDREWS Department of Chemistry, Gitam Institute of Technology, GITAM University, Visakhapatnam, India 530045
BOLINENI NAGESWARA RAO Research and Development, Divis Laboratories Limited, Hyderabad, India 500018

DOI:

https://doi.org/10.22159/ijap.2021v13i6.41915

Keywords:

Bilastine, Montelukast, Tablet formulation, Stability indicating, Analysis

Abstract

Objective: We have developed a “stability-indicating RP-HPLC” procedure for the Bilastine (BLS) and montelukast (MTL) analysis of tablets.

Methods: The quantification of BLS and MTL combination was implemented utilising a Waters column (C18, 5 μm, 250 mm and 4.6 mm). Isocratic mobile phase had 60% volume KH₂PO₄ of 0.1M strength with pH 4.2 units and 40% volume methanol at a flow with 1.0 ml/min speed. UV detection at 232 nm was done to examine BLS and MTL. Stability experiments of BLS and MTL under distinctive environments of stress were also performed.

Results: The BLS and MTL were eluted at 1.810 min and 2.551 min, respectively. The responses were found to be linear for the concentration ranges of 10-30 µg/ml (BLS) and 5-15 µg/ml (MTL). Percent comparative standard deviance for precision was 0.331% (BLS) and 0.486% (MTL). Percent assay for accuracy was 98.96% (BLS) and 99.00% (MTL). The detection limit and quantitation limit measures for BLS were 0.018 µg/ml and 0.059 µg/ml, respectively, while for MTL it was 0.024 µg/ml and 0.081 µg/ml, respectively. Robustness studies authorized that the method is robust with percent comparative standard deviance of a highest 1.950%.

Conclusion: The developed “stability-indicating RP-HPLC” procedure for the BLS and MTL analysis is simple, sensitive, precise, specific and robust, making it appropriate to the assessment of BLS and MTL in a tablet formulation.

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