Abstract
A simple and reproducible reversed-phase ion-pair high performance liquid chromatography (HPLC) method using isocratic elution with UV absorbance detection was developed and validated for the simultaneous determination of carboxylate (C) and lactone (L) forms of SN-38 (active metabolite of irinotecan) in nanoparticles (NPs). Reversed phase (RP) chromatography was performed on a C18 column with an ion-pair solution, KH2PO4 buffer solution and acetonitrile, under a mobile phase 30:30:40 (v/v) and at a flow rate of 1 mL/min. Detection was performed at 265 nm and sharp peaks were obtained for C and L forms of SN-38 at retention times of 2.9 ± 0.01 and 5.1 ± 0.01 min respectively. Linear regression analysis data for the calibration plot showed a good linear relationship between response and concentration in the range of 4 to 100 μg/mL; the regression coefficient was 0.9999 for L form and 0.9998 for C form. The optimized method showed good performance in terms of specificity, linearity, detection and quantitation limits, precision and accuracy in accordance with the International Conference on Harmonization (ICH) Q2 (R1) guidelines. This assay was demonstrated to be applicable for routine quantitation of SN-38 in PLGA NPs.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.