Asian Journal of Research in Chemistry

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Method Development and Validation of Montelukast Sodium in Bulk and Tablet Formulation by HPLC


Affiliations
1 Department of Quality Assurance Techniques, RG Sapkal College of Pharmacy, Anjaneri, Nashik, India
2 Department of Pharmaceutical Chemistry, RG Sapkal College of Pharmacy, Anjaneri, Nashik, India
3 University Institute of Chemical Technology, NMU, Jalgoan, India
     

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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.
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  • Method Development and Validation of Montelukast Sodium in Bulk and Tablet Formulation by HPLC

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Authors

Dipti G. Phadtare
Department of Quality Assurance Techniques, RG Sapkal College of Pharmacy, Anjaneri, Nashik, India
Amol R. Pawar
Department of Pharmaceutical Chemistry, RG Sapkal College of Pharmacy, Anjaneri, Nashik, India
Rajashri R. Kulkarni
Department of Quality Assurance Techniques, RG Sapkal College of Pharmacy, Anjaneri, Nashik, India
Govind K. Patil
University Institute of Chemical Technology, NMU, Jalgoan, India

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.