Development and Validation of Reverse Phase High Performance Liquid Chromatography Method for In-vitro Dissolution Testing of Bilastine and Montelukast Sodium Tablets

Abstract

The objective of this experimental work is to develop and validate a reverse-phase high-performance liquid chromatographic (RP-HPLC) method, which is capable of quantitative estimation of Bilastine (BLS) and Montelukast (MTK) content present in dissolution media accurately and precisely. A simple, fast, specific, rugged, and reproducible analytical method was developed and validated on a Shimadzu Highperformance liquid chromatography (HPLC) system. A Hypersil BDS C18-Column (100 mm x 4.6mm, 3 µm) and 0.1%v/v Triethylamine buffer (pH-3.0): Acetonitrile used as mobile phase with flow rate 1.0 mL/min in gradient mode. The column oven temperature and sample cooler temperature were set to 40°C and 25°C, respectively. The injection volume was 10 µL, and chromatograms were recorded at 220 nm. The run time for 1 sample analysis was 13 minutes. The optimized conditions for dissolution testing include USP type-II apparatus at 75 rpm with 900 mL, 0.5% w/v sodium lauryl sulfate media at 37.0 ± 0.5°C and collected after 45 minutes. Under the above conditions, the retention time (RT) of Bilastine and Montelukast was 1.84 and 7.23 minutes, respectively, without any interference of dissolution media or any other degradant at the RT of both drugs. The calibration curve was linear with R2 value of 0.99984 and 0.99988 for BLS and MTK, respectively. The sample was found stable in dissolution media beyond 12 hours. The analytical method was validated as per International Council for Harmonisation (ICH) guidelines with respect to specificity, precision, linearity, accuracy, stability in aqueous solution, and robustness. The proposed method was found useful for the routine analysis of dissolution samples for quality control purposes.