Development and Validation of a Stability-Indicating Liquid Chromatography Method for Simultaneous Determination of Bilastine and Montelukast in Pharmaceutical Formulations
Kancharla Vijayalakshmi *
Quality Control Department, Divis Laboratories Limited, Hyderabad, 508252, India.
Bethapudi Samuel Anand Andrews
Department of Chemistry, Gitam Institute of Technology, GITAM University, Visakhapatnam, 530045, India.
Bolineni Nageswara Rao
Research and Development, Divis Laboratories Limited, Hyderabad, 500018, India.
*Author to whom correspondence should be addressed.
Abstract
Background: Bilastine (BLS) and montelukast (MTL) are commonly co-administered in the management of allergic conditions such as allergic rhinitis and asthma. However, there is limited availability of validated stability-indicating liquid chromatography methods for their simultaneous estimation in combined pharmaceutical formulations.
Objective: A stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous estimation of bilastine (BLS) and montelukast (MTL) in tablet dosage forms.
Methods: The RP-HPLC analysis was performed using a Waters 2965 HPLC system equipped with a PDA 2998 detector. 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 rate of 1.0 ml/min. UV detection at 232 nm was done to examine BLS and MTL. The method was validated as per ICH guidelines for parameters including selectivity, linearity, precision, accuracy, robustness, and specificity. 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). Per cent comparative standard deviance for precision was 0.331% (BLS) and 0.486% (MTL). Per cent 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 confirmed that the method is robust with percent comparative standard deviance of a highest 1.950%.
Conclusion: The proposed stability-indicating RP-HPLC method is simple, sensitive, precise, accurate, specific, and robust. It is suitable for routine analysis of bilastine and montelukast in combined tablet formulations.
Keywords: Bilastine, montelukast, tablet formulation, stability indicating, analysis