PMID- 30590524 OWN - NLM STAT- MEDLINE DCOM- 20190321 LR - 20190321 IS - 1945-239X (Electronic) IS - 0021-9665 (Linking) VI - 57 IP - 3 DP - 2019 Mar 1 TI - Fingerprint Analysis and Multi-Component Determination of Ribonucleic Acid for Injection II Recipe by HPLC-DAD and LC-ESI-MS Methods. PG - 238-242 LID - 10.1093/chromsci/bmy105 [doi] AB - Using high-performance liquid chromatography (HPLC), a quantitative method was developed to control the quality of ribonucleic acid for injection II (RA-II), which is used as an anti-cancer drug clinically in China. Using nuclease enzyme and under optimal hydrolysis conditions, the unstable RNA was hydrolyzed into stable nucleosides and nucleotides, which were easily detected by HPLC with diode array detection. Furthermore, by analyzing HPLC chromatograms of 10 batches of samples, six common peaks, namely, cytosine nucleotide, uracil nucleotide, adenine nucleotide, guanine nucleotide, guanosine and adenine, were identified by a HLPC coupled with electrospray ionization mass spectrometry. The similarity, the relative retention time and the relative peak area of each common peak, relative to the reference peak, were calculated to obtain the HPLC fingerprints, and their values were within the scope of the provisions. More importantly, all six components were simultaneously determined. Overall, the developed method in this investigation proved to be a useful tool for monitoring the quality of RA-II in terms of their batch variations and the raw material sources. FAU - Zheng, Wei AU - Zheng W AD - Departments of Ophthalmology, The Affiliated Hospital, Changchun University of Chinese Medicine, No 1478, Gongnong Road, Changchun, Jilin, China. FAU - Xu, Duoduo AU - Xu D AD - Center of Research & Development, Changchun University of Chinese Medicine, No 1035, Boshuo Road Changchun, Jilin, China. AD - Macromolecule of Chinese Medicine Key Lab of Jilin Province, Changchun, Jilin, China. FAU - Wang, Mingxing AU - Wang M AD - Preparation Center, The Affiliated Hospital, Changchun University of Chinese Medicine, Changchun, Jilin, China. FAU - Zhang, Yanqiu AU - Zhang Y AD - Preparation Center, The Affiliated Hospital, Changchun University of Chinese Medicine, Changchun, Jilin, China. FAU - Gao, Qipin AU - Gao Q AD - Center of Research & Development, Changchun University of Chinese Medicine, No 1035, Boshuo Road Changchun, Jilin, China. AD - Macromolecule of Chinese Medicine Key Lab of Jilin Province, Changchun, Jilin, China. FAU - Gao, Yang AU - Gao Y AD - Center of Research & Development, Changchun University of Chinese Medicine, No 1035, Boshuo Road Changchun, Jilin, China. AD - Macromolecule of Chinese Medicine Key Lab of Jilin Province, Changchun, Jilin, China. LA - eng PT - Journal Article PL - United States TA - J Chromatogr Sci JT - Journal of chromatographic science JID - 0173225 RN - 63231-63-0 (RNA) SB - IM MH - China MH - Chromatography, High Pressure Liquid/*methods MH - Limit of Detection MH - Linear Models MH - RNA/analysis/*chemistry MH - Reproducibility of Results MH - Spectrometry, Mass, Electrospray Ionization/*methods EDAT- 2018/12/28 06:00 MHDA- 2019/03/22 06:00 CRDT- 2018/12/28 06:00 PHST- 2017/10/10 00:00 [received] PHST- 2018/12/28 06:00 [pubmed] PHST- 2019/03/22 06:00 [medline] PHST- 2018/12/28 06:00 [entrez] AID - 5257451 [pii] AID - 10.1093/chromsci/bmy105 [doi] PST - ppublish SO - J Chromatogr Sci. 2019 Mar 1;57(3):238-242. doi: 10.1093/chromsci/bmy105.