METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SERTRALINE AND DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
Objective: The aim of this work was to develop and validate a simple Reversed Phase - High Performance Liquid Chromatography method for the simultaneous estimation of Sertraline and Doxofylline in pharmaceutical dosage form.
Methods: The mobile phase consists of Phosphate buffer and Acetonitrile in the ratio of (30:70) with gradiant programming, Kromasil C18(150Ã—4.6 mm,5Âµ) column used as stationary phase with a flow rate of 1 ml/min, injection volume 10 Âµl and the run time was 7 min. Detection wavelength was at 234 nm by using Photo Diode Array detector.
Results: The retention times of Doxofylline and Sertraline retention were found to be 2.82 min and 3.93 min, respectively. The method was validated according to ICH guidelines. Validation parameters like accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness all were within the limits. The linearity responses of Doxofylline and Sertraline were found to be in the concentration ranges of 100-600 ppm and 12.5-75 ppm. The percentage recovery for both drugs were found in the range of 99-100%. The LOD & LOQ values for Doxofylline were found to be 0.58 and 1.77Âµg/ml and Sertraline were found to be 0.27 and 0.82 Âµg/ml, respectively.
Conclusion: The results obtained are accurate and within the limits. Hence this method can be applicable for the estimation of Doxofylline and Sertraline in pharmaceutical dosage forms.
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