Development and Validation of Analytical Method for Simultaneous Estimation of Montelukast and Doxyfylline by Rp-hplc
Year: 2024
Type: dissertation
Abstract: The development and validation of a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Montelukast and Doxofylline in pharmaceutical formulations were carried out. The method was optimized using a Waters HPLC system equipped with an auto-sampler and PDA detector (996 model). A Phenomenex Luna C18 column (4.6×250mm, 5µm) was employed for the separation of both drugs. The mobile phase consisted of acetonitrile and phosphate buffer (pH 4.6) in a 45:55 (v/v) ratio, with a flow rate of 1.0 ml/min. The wavelength for detection was set at 245 nm, and the injection volume was 10 µL. The column temperature was maintained at 35°C, and the total run time was 7 minutes. The method was validated as per ICH guidelines, and the results demonstrated excellent linearity, precision, accuracy, and robustness. The proposed method offers a simple, rapid, and reliable approach for the simultaneous estimation of Montelukast and Doxofylline in tablet dosage forms, and can be effectively used for quality control in pharmaceutical industries. Keywords: Montelukast and Doxofylline, RP-HPLC, Simultaneous Estimation, Pharmaceutical Dosage Forms, Waters HPLC.
Author: MD. Sohail Ahmed*, Dr. Gadipally.Sai Kiran, Dr.D. Venkata Ramana
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: green
OpenAlex ID: W6930480680
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