A Validated Stability Indicating HPTLC Method for Bilastine and Montelukast in Pharmaceutical Dosage Form

Abstract

An accurate and precise and robust method has been described for Stability Indicating HPTLC method for development and validation for Bilastine and Montelukast in pharmaceutical dosage form. The separation carried out on silica gel 60F254 by using mobile phase of Toluene: Methanol 6.5:3.5 v/v. Linear regression shows a good in the range of 200-1200ng/spot and 100-600ng/spot for Bilastine and Montelukast with regression line equation y = 8.4512 X + 129.3 with r2 > 0.9985 and y = 5.6208 X + 2179.9 with r2 > 0.993. The 243nm was selected as detection wavelength. The Rf value was found to be 0.31±0.01 and 0.61±0.01 for Bilastine and Montelukast respectively. The Intraday precision was found to be 0.79–0.95% for Bilastine and 0.26–0.91% for Montelukast. The Interday precision was found to be 0.78–1.21% for Bilastine and 0.24–0.72% for Montelukast. Accuracy was performed by recovery study. The % recovery was found to be 99.49 to 101.78% for Bilastine and 98.6 to 101.76% for Montelukast. The LOD was found to be 26.26ng/spot for Bilastine and 33.34ng/spot for Montelukast. The LOQ was 79.60ng/spot for Bilastine and 99.64ng/spot for Montelukast. The Assay of Bilastine and Montelukast amount found to be 100.14% and 99.10% respectively. Forced Degradation studies were carried out at various conditions. In Acidic condition the % degradation of Bilastine and Montelukast was found to be 5.84% and 16.72% respectively. In Alkaline and Oxidative condition, the %degradation of Bilastine and Montelukast was found to be 26.95% and 17.61%. and 32.22% and 9.25% respectively. In Photolytic condition the %degradation was found to be 14.94% and 15.65% respectively for Bilastine and Montelukast. In Thermal condition the %degradation was found to be 17.54% and 14.65% respectively for Bilastine and Montelukast.