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  DOI Prefix   10.20431


 

ARC Journal of Pharmaceutical Sciences
Volume 3, Issue 1, 2017, Page No: 7-18
doi:dx.doi.org/10.20431/2455-1538.0301004

Analytical Method Development and Validation for Simultaneous Estimation of Doxofylline and Montelukast Sodium in Bulk and Pharmaceutical Dosage Form

S.Marakatham,1*,B.Divya1, Meruva Sathish Kumar1

Malla Reddy Institute of Pharmacy, Maisammaguda, Secunderabad.

Citation :S.Marakatham,B.Divya, Meruva Sathish Kumar, Analytical Method Development and Validation for Simultaneous Estimation of Doxofylline and Montelukast Sodium in Bulk and Pharmaceutical Dosage Form ARC Journal of Pharmaceutical Sciences 2017,3(1) : 7-18

Abstract

rapid, precise and accurate reverse phase high performance liquid chromatographic method have beendeveloped for the validated of DOXOFYLLINE AND MONTELUKAS SODIUM, in its original form as well as in pharmaceutical dosage form. Chromatography conditionswas carried out on a Phenomenex HYPERSIL ODS, RP-18,250 X 4.6mm ID, column using a mixture of Ammonium acetate: Methanol (60:40) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 219nm. The retention time of the DOXOFYLLINE AND MONTE LUKAS SODIUM was 2.34,4.81±0.02min respectively. The method produce linearity responses in the range of 1.5-3.5mg/ml of DOXOFYLLINE and 60-140mg/ml of MONTELUKAS SODIUM. The limit of detection of Montelukast & Doxofylline 0.021 µg/ml & area 2.61 and 1.54 μg/ml & area 104.45 respectively. The limit of quantitation of Montelukast was found to be 0.06μg/ml & area 7.91 whereas for Doxofylline was 4.68 μg/ml & area 316.51. The percentage of recovery of Montelukast and Doxofylline was found to be 99.96% and 100.85% respectively. The method is useful for the quality and quality control of bulk and pharmaceutical formulations.


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