An HPLC Method for Simultaneous Quantification of Sunitinib and its Active Metabolite, Su12662, Using Hydrophilic Interaction Chromatography Principle
Murari Gurjar, Parsshava Mehta, Jyoti Sharma, Sneha Patil, Preeti Kulkarni, Anand Patil, Manjunath Nookala, Amit Joshi, Vikram Gota
Abstract
Aim: To develop a sensitive HPLC method for the quantitation of sunitinib (SU) and its active metabolite N-desethyl-sunitinib (SU12662) in human plasma. Materials & methods: The analytes were extracted from 500 μl of plasma using liquid–liquid extraction followed by protein precipitation. Chromatographic separation of two analytes and internal standard, vandetenib, was achieved on a hydrophilic interaction liquid chromatography analytical column using a gradient program. Calibration curves were linear over the range of 10–250 ng/ml for both SU and SU12662. The method was validated according to the US FDA guidelines for bioanalytical methods. Accuracy of the method at 10 ng/ml for SU and SU12662 was 8.7 and 6.7%, respectively, and precision was 10.18% and 17.3%, respectively. Conclusion: This method allows a specific, sensitive and reliable determination of SU and SU12662 in human plasma in a single analytical run which makes it useful for therapeutic drug monitoring.