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Asian Journal of Research in Chemistry
Year : 2016, Volume : 9, Issue : 7
First page : ( 339) Last page : ( 342)
Print ISSN : 0974-4169. Online ISSN : 0974-4150.
Article DOI : 10.5958/0974-4150.2016.00051.1

Method development and validation of Montelukast sodium in bulk and tablet formulation by HPLC

Phadtare Dipti G.2,*, Pawar Amol R.1,*, Kulkarni Rajashri R.2, Patil Govind K.3

1Department of Pharmaceutical Chemistry, RG Sapkal College of Pharmacy, Anjaneri, Nashik

2Department of Quality Assurance Techniques, RG Sapkal College of Pharmacy, Anjaneri, Nashik

3University Institute of Chemical Technology, NMU, Jalgoan

*Corresponding Author E-mail: amolpharma9@gmail.com

Online published on 18 October, 2016.

Abstract

A high performance liquid chromatography method has been developed and validated method for the simultaneous estimation of Montelukast sodium in bulk and tablet dosage form. The method was carried out using Princeton SPHER ULTIMA C18 100A 5μ 250*4.6 mm using OPA: Methanol (10: 90 v/v) as mobile phase at flow rate 1ml/min. HPLC separation was carried out at 284 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9982 and 0.9979 for Montelukast sodium in bulk and tablet dosage form respectively in the concentration range of 1–6 μl/ml for Montelukast sodium in bulk and tablet dosage form. The method was validated for precision, robustness, specificity and accuracy. The limit of detection and quantitation were 0.0011 and 0.0033 μg/ml. the proposed HPLC method can be applied for identification and quantitative determination of Montelukast sodium in bulk and tablet dosage form.

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Keywords

Montelukast sodium, tablet, HPLC, validation.

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