Abstract
Aim: This study proposes to develop and validate the RP-HPLC method for Bilastine and Montelukast and to substantiate the RP-HPLC analysis bestowing to ICH validation guideline Q2R1.
 Place and Duration of Study: Y. B. Chavan College of Pharmacy, Aurangabad, MS, India, between January 2020 and October 2021.
 Methodology: The mixture of drugs was subjected to optimization by trial runs with different chromatographic parameters, viz. flow rate, λ in nm, etc. The system suitability was performed by repeated injections of Bilastine (200µg/mL) and Montelukast (200µg/mL) to confirm the optimization. Furthermore, the demonstrated method was validated as per ICH Q2R1 recommendations for parameters like accuracy, precision, robustness, the limit of detection and quantitation, etc.
 Results: The outcomes of the method in terms of percent relative standard deviation (%RSD) of retention time (RT) and mean peak area were seen as 0.09, 0.35, and 0.35, 0.56 for Bilastine and Montelukast, respectively. The method was successful in achieving the qualifying criteria entrusted to ICH guidelines. The correlation coefficient, slope, and y-intercept were illustrated to be 0.9971, 17595, 217883, 0.998, 35458, and 17147, correspondingly for Bilastine and Montelukast, respectively. The range was seen in the order of 160-260µg/mL and 80-130µg/mL for Bilastine and Montelukast. The precision of the method was established with %RSD of repeatability and intermediate precision was < 2 at three standard levels across the range. The %accuracy of the method was observed in the range of 96.95-101.41 %w/w and 97.37-101.89 %w/w in the order for Bilastine and Montelukast. The robustness of the method displayed the results within the prescribed boundaries. The recovered amount of Bilastine and Montelukast by spike method was observed to be 96.37-98.88 %w/w and 96.11-100.06%w/w.
 Conclusion: The author has accomplished the predefined goals by successful development and validation of the RP-HPLC method for the quantification of Bilastine and Montelukast as per ICH Q2R1 guidelines.
Highlights
The efficiency and speed of High-Performance Liquid Chromatography (HPLC) have proved the method’s development requirements in the past 30 years [1,2]
This formulation was used to recover the amount of Bilastine and Montelukast from the pharmaceutical tablet dosage form to ensure the applicability of the method for a custom analysis of the fixed-dose combination
Limit of detection (LOD) and Limit of quantitation (LOQ) for Bilastine and Montelukast was calculated from the resultant formulae
Summary
The efficiency and speed of High-Performance Liquid Chromatography (HPLC) have proved the method’s development requirements in the past 30 years [1,2]. The HPLC has proved to be the most valuable technique for a custom analysis of peptides [3,4]. HPLC is the first choice of analytical scientists for qualitative and quantitative analysis of drug substances and drug products. HPLC is competent enough to separate the most complex mixtures [5,6]. CysLT’s like LTC4, LTD4, and LTE4 [10]. The outcome of this inhibition is the prevention of the symptoms of allergic rhinitis and asthma [11,12].
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