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

Mr. Pavan Nathu Patil; Miss. Harshada Ravindra Patil

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

Authors:
Miss. Harshada Ravindra Patil | Mr. Pavan Nathu Patil

Cite This Article :

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, pp.1039-1046, URL: https://www.ijtsrd.com/papers/ijtsrd29809.pdf

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Abstract :
? 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.

Keywords :
Montelukast tablet, RP-HPLC, Degradation studies, Validation, ICH guidelines.

Publication Details:

Unique Identification Number : IJTSRD29809

Published In : Volume-4 | Issue-1, December 2019

Page Number(s) : 1039-1046

Publisher Name : IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470

Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

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