Journal :   Asian Journal of Research in Chemistry

Volume No. :   8

Issue No. :  7

Year :  2015

Pages :   339-342

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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



Address:   Dipti G. Phadtare2*, Amol R. Pawar1*, Rajashri R. Kulkarni2, Govind K. Patil3
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
DOI No: 10.5958/0974-4150.2016.00051.1

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.
KEYWORDS:
Montelukast sodium, tablet, HPLC, validation.
Cite:
Dipti G. Phadtare, Amol R. Pawar, Rajashri R. Kulkarni, Govind K. Patil. Method development and validation of Montelukast sodium in bulk and tablet formulation by HPLC. Asian J. Research Chem. 2016; 9(7): 339-342.
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