Category: Formulation and Quality
Purpose: We developed a stability enhanced nano shell (SENS) delivery system composed of an amphiphilic block copolymer, anionic polymer, cationic lipid, helper lipid and anionic siRNA. These synthetic polymers or lipids are used as one of the carriers in oligonucleotide delivery system.
So, a method to quantitative total siRNA in siRNA-polymeric nanoparticle formulation using AEX-HPLC was developed.
Methods: Chromatographic analysis was performed on TSKgel DNA-STAT column (4.6x 100 mm, 5 μm). The mobile phase was Tris-HCl buffer (50mM, pH 8.0) with linear gradients using 1 M NaCl as eluting salt at a flow rate of 0.8 mL/min.The detection was performed at UV wavelength of 260 nm and injection volume was 50 μL.
Results: A linear calibration curve was obtained in the concentration range of 100~1,000 ㎍/mL for total siRNA. The correlation coefficient was above 0.99.
Conclusion: This method was validated and showed to be high specific, precise and accurate.
Jiyeong Kim– Deputy Senior Manager, Instrument analysis/ R&D center/ Samyang Biopharmaceuticals corp., Seongnamsi, Kyonggi-do, Republic of Korea
hyerim kim– Seongnam-si, Kyonggi-do, Republic of Korea
Sukyen Ko– Samyang Biopharmaceuticals Corporation, Seongnam, Kyonggi-do, Republic of Korea