BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF BOSENTAN IN HUMAN PLASMA
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Objective: A new simple and precise bioanalytical reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Bosentan in human plasma. Materials and Methods: The developed method was successfully used for assaying drug contents in human plasma. Isocratic elution mode was carried at Shimadzu HPLC equipment comprising of binary LC 10AT vp pumps, SIL 10AD vp Autosampler, Phenomenex C18 column (150 mm × 4.6 mm, 5 μm particle size) using 20mM Sodium acetate buffer (pH 4.0) and methanol (35:65) as mobile phase at flow rate 1.0 ml min at detection wavelength 220 nm. Orniidazole was taken as an internal standard. The method was validated as per ICH M10 guidelines. Results and Discussion: The present validated method can be successfully applied for the estimation of Bosentan in human plasma over the concentration range of 52.5-3089.48 ng/mL. The method for the determination of prazosin and polythiazide in human plasma using HPLC detection met the acceptance criteria with respect to selectivity, precision, accuracy, linearity, and recovery. Conclusion: The proposed method is simple, rapid, accurate, precise, and appropriate for pharmacokinetic and therapeutic drug monitoring in the clinical laboratory
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