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Quality by Design Based Method Development for Simultaneous Estimation of Montelukast Sodium and Theophylline in Tablet Dosage Form


Kunti Abhishek Shah and Vijay Parmar*   Pages 1 - 10 ( 10 )


Background: Analytical Quality by design (AQbD) is one of the upcoming regulatory requirements in the field of pharmaceutical analysis for the development of reliable and robust analytical methods. Montelukast sodium and theophylline available in tablet dosage forms are used widely for the treatment of airway disorders. Liquid chromatographic methods for estimation of the drugs are reported but those chromatographic methods developed by the AQbD approach are not available. Method: A systematic design of experiments has been employed to develop a liquid chromatographic method for simultaneous estimation of montelukast sodium and theophylline. Critical process parameters are defined and optimization of methanol content in mobile phase, the concentration of trifluoroacetic acid and flow rate was employed within the framework of the full factorial design. The statistical analysis of the experimental data for critical quality attributes namely tailing factor of both the drugs and resolution was performed. Results: A multi-dimensional design space for the critical process parameters was obtained. The optimal chromatographic separation of the two API was achieved using C18 (250mm


Montelukast, theophylline, HPLC, quality by design, design of experiments


Ramanbhai Patel College of Pharmacy - Pharmaceutical Chemistry and Analysis Anand, Gujarat, Ramanbhai Patel College of Pharmacy - Pharmaceutical Chemistry and Analysis

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