Quality Control Of Oligonucleotides Using HPLC Coupled To UV And MS Detection

Therapeutic oligonucleotides are increasingly vital in pharmaceutical research, requiring rigorous analytical methods for quality assurance. This study highlights a robust workflow utilizing ion-pair reversed-phase (IP-RP) HPLC coupled with UV detection and mass spectrometry (MS). The dual-method approach ensures accurate mass confirmation and impurity identification, overcoming challenges like co-eluting byproducts such as N-1 sequences and depurination products.

By employing advanced separation techniques, impurities that escape baseline resolution in chromatography can be quantified with precision via mass spectrometry. The methodology, validated with a 26-mer oligonucleotide, underscores the synergy between UV's quantification capabilities at 260 nm and MS's sensitivity to molecular nuances. Enhanced by collaboration with BianoGMP GmbH, this workflow demonstrates how combining UV and MS advances therapeutic oligonucleotide analysis, aligning with GMP standards.

Discover the full potential of this integrated analytical solution and elevate your oligonucleotide quality control processes.