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Research Journal of Science and Technology
ISSN: 2349-2988(Online), 0975-4393(Print)
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Development and Validation of RP-HPLC Method for the Estimation of Montelukast Sodium in Bulk and In Tablet Dosage Form
G. S. Chhabra
Nishant Sarode1*, G. S. Chhabra2, Shailesh Luhar1 and Anil Jadhav1
1Smt. BNB Swaminarayan College of Pharmacy, Salvav, Vapi. Gujarat 396191
2SPTM, NMIMS, Babulde, Bank of Tapi River, Mumbai – Agra Road, Shirpur, Dist. Dhule, Maharashtra - 425405
A simple, selective and rapid reverse phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Montelukast Sodium in bulk and in tablet dosage form has been developed and validated. Sample was resolved on a Luna Phenomenax, C18 (150mm X 4.6 mm i.d., particle size 5µ) column. The mobile phase consisted of Acetonitrile l : 20 mM phosphate buffer ( 80:20 v/v pH adjusted to 6.0 by using KOH ) was delivered at a flow rate of 1.0 ml/min at ambient temperature and the retention time was about 9.92 minutes. Studies were performed on an HPLC system equipped with a UV/Visible detector at 213nm. The method is specific to Montelukast sodium and able to resolve the drug peak from formulation excipients. The calibration curve was linear over the concentration range of 25-150 µg/ml (R=0.9991).The results of analysis of formulation was found to be 99.80 ± 0.3268. The proposed method is applicable to routine analysis of Montelukast sodium in bulk and in tablet dosage form.
Montelukast Sodium, RP-HPLC, validation.
Nishant Sarode, G. S. Chhabra, Shailesh Luhar, Anil Jadhav. Development and Validation of RP-HPLC Method for the Estimation of Montelukast Sodium in Bulk and In Tablet Dosage Form. Research J. Science and Tech. 2011; 3(5): 257-260.
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