Application of LC-MS in the analysis of therapeutic oligonucleotide drugs
Therapeutic oligonucleotides(OGNs)drugs are artificially synthesized single or double stranded short nucleic acids,typically 15 to 30 base pairs in length.OGNs have been rapidly developed as new therapeutic drugs with increasing attention in the discovery and development of drugs concerning various disease fields.Compared with Europe and America,there are currently no other OGNs drugs listed in China,except for Spinraza,which has been approved for marketing as an orphan drug.The development of OGNs in China started relatively late and is still in its early stages of development.However,the OGNs drug market in China is anticipated to grow quickly due to the country's large population,high patient demand,ongoing support for the development of oligonucleoti-de drugs in the future,and the steady maturation of related technologies by domestic businesses.Because of their special physicochemical characteristics,OGNs drugs are challenging to design biological analysis techniques.Cur-rently,there are few reports on quantitative analysis methods for oligonucleotide drugs in China.Therefore,the development of sensitive and reliable bioanalysis methods for oligonucleotides is the key to investigate oligonucle-otides'pharmacokinetic and pharmacodynamic properties.Liquid chromatography-mass spectrometry(LC-MS)can quantify OGNs and their metabolites concurrently,compared with traditional ELISA approaches.Numerous ben-efits come with using LC-MS,in particular,the extensive use of high-resolution mass spectrometry allows for the identification of metabolites,which provides details on base composition and sequence structure,in addition to quantitative information about target oligonucleotides.It has now emerged as the go-to technique for OGN quantita-tive analysis.The application of LC-MS in the identification of therapeutic oligonucleotide medicines is the primary focus of this paper,which also discusses its benefits and drawbacks.Lastly,it looks at the LC-MS development trend for oligonucleotide detection,which includes a lower detection level and potential general methods.
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