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Development and Validation of a Novel LC Method for the Simultaneous Determination of Montelukast and Doxofylline in Bulk and Pharmaceutical Dosage Forms | Chapter 12 | Challenges and Advances in Chemical Science Vol. 4

 For the simultaneous determination of montelukast and doxofylline in bulk and pharmaceutical dose forms, a novel fast HPLC approach was devised. The development of an analytical method for simultaneous drug estimation necessitates a significant amount of effort and is, without a doubt, a difficult task. The method was created using a C18 column (150 mm 4.6 mm, 5 (mu)(mu)m); a mobile phase of methanol and phosphate buffer at pH 4.5; a flow rate of 1.0 mL/min; and UV detection at 280 nm. Montelukast and doxofylline were both satisfactorily resolved, with retention times of 4.7 and 1.9 minutes, respectively. The method was validated as per ICH Guidelines for various parameters like precision, linearity, accuracy, ruggedness, and robustness. The validated method was applied to the commercially available pharmaceutical dosage form and obtained the desired result. It is concluded that this method can be used by the industries and academic institutions for their combination drug estimation, which is fast as well as novel.

Author (S) Details

Gadapa Nirupa
Department of Chemistry, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad 500 085, India.

Upendra M. Tripathi
Analytical R&D Department, Startech Labs Pvt Ltd, 2nd Floor, SMR Chambers, H. No. 1-58/7 Madinaguda, Hyderabad 500 050, India.


View Book :- https://stm.bookpi.org/CACS-V4/article/view/3052

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