All submissions of the EM system will be redirected to Online Manuscript Submission System. Authors are requested to submit articles directly to Online Manuscript Submission System of respective journal.

Abstract

Development and validation of a RP-HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form

Author(s): RM Singh1, PK Saini1, SC Mathur1, GN Singh1, B Lal2
1 Research and Development Division, Indian Pharmacopoeia Commission, Sector-23, Rajnagar, Ghaziabad-201 002, India 2 Department of Pharmaceutical Analysis, Faculty of Pharmacy, Vinayaka Mission University, Salem-636 015, India

Correspondence Address:
R M Singh Research and Development Division, Indian Pharmacopoeia Commission, Sector-23, Rajnagar, Ghaziabad-201 002 India E-mail: [email protected]


The present work describes a simple, precise and accurate HPLC method for estimation of montelukast sodium in bulk and in tablet dosage form. The separation was achieved by using octadecylsilane column (C18) and acetonitrile:1 mM sodium acetate adjusted to pH 6.3 with acetic acid in proportion of 90:10 v/v as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 285 nm. The retention time of montelukast sodium was found to be 3.4 min. The limit of detection was found 1.31 μg/ml and limit of quantification 3.97 μg/ml. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (1-100 μg/ml), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of montelukast sodium in bulk and in tablet dosage form.



Share this