Articles Accepted

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF BILASTINE AND MONTELUKAST SODIUM FROM THEIR COMBINED TABLET DOSAGE FORM
by Mr. Ankit Kushwaha, 02 May 2021
Co-Author(s): Binny D Mehta

A simple, precise and accurate newly developed and validated method for the Stability Indicating High Performance Thin Layer Chromatography (HPTLC) method for quantitative determination of Bilastine (BILAS) and Montelukast Sodium (MONTE) from its combined pharmaceutical dosage form. High Performance Thin Layer Chromatography separation and quantification was carried out on Merck HPTLC Aluminium plates of silica gel 60 F254, (20 x 20 cm) with 250µm thickness using Chloroform: Toluene: Methanol: Glacial acetic acid (4:4:2:0.1 V/V/V/V) as mobile phase solvent system. This solvent system give the Rf value of 0.21 for BILAS and Rf value of 0.49 for MONTE respectively. Densitometric analysis of BILAS and MONTE was done at 226 nm. Regression analysis for the calibration plots was indicative of good linear relationship with r2 = 0.9979 and 0.9952 for BILAS and MONTE respectively, in the concentration range of 2 - 10 µg/spot for BILAS and 1 - 5 µg/spot for MONTE. The method was validated for precision, repeatability, limit of detection, limit of quantification, robustness, specificity, accuracy and assay. Forced degradation studies were performed under different conditions. In the present research, stability indicating HPTLC method has been developed and validated for both the drugs.

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