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Original Article

Method development and validation of LC–ESI–MS/MS method for the quantification of sonidegib in healthy rabbits

Vankayala Devendiran Sundar, Kumar Raja Jayavarapu, Parimala Krishnan.

A new, specific, and precise liquid chromatography–electrospray ionization–tandem mass spectrometric (LC–ESI–MS/ MS) technique was established and validated for the quantitation of sonidegib in plasma. The established procedure was applied to the pharmacokinetic study in rabbits. Chromatographic separation was achieved on Phenomenex-C18 (50 × 4 mm) 5-µm column and on methanol, acetonitrile and 0.1% formic acid (25:60:15 by volume) mixture as a movable phase monitored at a flow rate of 0.70 ml/minutes. Sonidegib and gliquidone internal standard were noted at m/z 486.2/191.1 and m/z 528.5/403.4, respectively. Sonidegib and gliquidone were extracted with liquid–liquid extraction. The developed procedure was linear in the concentration range of 103–1,545 ng/ml. The method was validated with intrabatch and interbatch precision and accuracy within 1.54%–7.18%, 1.82%–6.25%, 98.56%– 102.80%, and 97.62%–102.76%, respectively. The technique was applied for the successful examination of the rabbit plasma sample for application in the pharmacokinetic study. This study was carried out on rabbits; the drug showed that Tmax was 3.833 hours, Cmax was 677.667 ± 19.81 ng/ml, andAUC0→t was 6,213.58 ± 235.4. The established technique was utilized in the regular examination of sonidegib in biological matrices with a high level of accuracy and precision.

Key words: Sonidegib, Basal cell carcinoma, LC-ESI-MS/MS, Pharmacokinetics, Precision and Accuracy.

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