Development and Validation of Stability Indicating Assay Method of Montelukast Tablet by RP-HPLC

Background A simple, precise cost effective stability indicating assay method of Montelukast by RP HPLC. Material Chromatographic separation was achieved on a Meteoric core C18 column 100mm x 4.6 mm, 2.7µm using a mobile phase 2 ml Trifluroacetic acid mixture of acetonitrile 250ml and methanol 400ml 350 650 at a flow rate of 1.5ml per minute. Wavelength was detection at 255nm. The retention time of Montelukast was 4 minutes. Results The method was found linear concentration the range of 120.39 802.57µg ml, tablet analysis of RSD 0.403, accuracy range 30 , 50 , 100 , and 200 , Precision RSD 0.3. The proposed method was validated as per the ICH guidelines. Conclusion The HPLC method was validated and demonstrated good linearity, precision, accuracy, specificity, robustness and stability indicating. The development HPLC method can be utilized for routine analysis stability studies for Montelukast. Miss. Harshada Ravindra Patil | Mr. Pavan Nathu Patil "Development and Validation of Stability Indicating Assay Method of Montelukast Tablet by RP-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29809.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/29809/development-and-validation-of-stability-indicating-assay-method-of-montelukast-tablet-by-rp-hplc/miss-harshada-ravindra-patil