Research progress in quantitative analysis methods for chemical reference substances

doi:10.19803/j.1672-8629.20230407

Abstract

Abstract: Objective To study the quantitative analysis methods for chemical reference substances, so as to offer evidence and suggestions for drug quality regulation, drug safety evaluation and drug testing and research institutes that performing the establishment of reference substances. Methods The basic principles, scope, and influencing factors of the cutting-edge quantitative analysis methods of chemical drug standard substances were introduced. The pros and cons between different methods were compared and stated. Results and Conclusion Pharmaceutical Reference substances are the material basis for drug development, quality control testing, safety monitoring and etc., which are crucial to the insurance of the drug quality and the implementation of pharmaceutical specifications. The largest category among Pharmaceutical Reference standards are chemical drug reference substances, which makes the accuracy of their value are of vital importance. The applicability of each method should be fully considered in order to choose the most appropriate method in quantitative analysis of the chemical reference substances.

Key words: chemical drugs, reference substances, quantitative analysis methods, drug testing, primary method, safety evaluation, quality control

CLC Number:

R917

TAN Liyuan, CAI Tong, WANG Yan. Research progress in quantitative analysis methods for chemical reference substances[J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1209-1216.

References

[1] ZHANG QH, YANG JS, JIAO H, et al.Advancement in organic chemical purity measurement by mass balance method[J]. Chemical Reagents(化学试剂),2020, 42(8): 931-939.
[2] ZHENG ZF, LIU WX, JIN WJ, et al.Progress on reference materials based on mass balance method[J]. Current Biotechnology(生物技术进展), 2020, 10(6): 623-629.
[3] ZHOU JY, HUANG YJ, XU JB, et al.Development of acid orange Ⅱ purity reference material[J]. Acta Met Rologica Sinica(计量学报), 2020, 41(9): 1163-1170.
[4] XIONG J, YAN J, LIU Y, et al.Development of the first national reference substance of favipiravir as a candidate drug against COVID-19[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(1): 52-61.
[5] LIU B, REN LP, ZHANG T, et al.Verification of national reference standard of N-glycyl-L-tyrosine[J]. Chinese Pharmaceutical Journal(中国药学杂志), 2020, 55(22): 1890-1894.
[6] ZHANG Y, GENG Y, ZHU RD, et al.Standardization of the first batch of national reference standard of brimonidine tartrate[J]. Chinese Journal of New Drugs(中国新药杂志), 2021, 30(2): 178-181.
[7] DING XL, LYU P, CAI YQ, et al.Development of the first national reference standard of beinaglutide[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2022,42(1): 78-85.
[8] LENG XY, SHI SD, LI YR, et al.Quantitative determination of gluconic acid in oral solution by NMR[J]. Chemical Reagents(化学试剂), 2019, 41(6): 598-602.
[9] LI JW, GUO HB, MA TT, et al.Application of nuclear magnetic resonance spectroscopy in drug quality and safety[J]. Guangdong Chemical Industry(广东化工), 2023, 50(10): 195-196.
[10] PAN JY, ZHAO F, LI WZ, et al.Quantitative NMR spectroscopy and its application in quality control of Chinese medicinal injection[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2022, 47(3): 569-574.
[11] HUANG ZH, CAI DD, ZHUO KY.Analysis and identification of a new dithio-carbodenafil analogue in health foods[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2018, 35(7): 991-994.
[12] ZHANG TS, SHANG SY, ZHAO ZM, et al.Qualitative and quantitative research of arbidol hydrochloride tablets based on quantitative nuclear magnetic resonance[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2022, 39(4): 507-511.
[13] HAO HJ, JIA YZ, HAN R, et al.Determination of gefitinib by two methods of quantitative nuclear magnetic resonance[J]. Chinese Journal of Pharmaceuticals(中国医药工业杂志), 2017, 48(5): 711-715.
[14] WU XF, XIAO XY.Nuclear magnetic resonance spectroscopy in pharmaceutical applications[J]. Chinese Journal of Pharmaceutical Analysis(药物分析杂志), 2020, 40(11): 1907-1913.
[15] PAN JY, ZHAO F, LI WZ, et al.Quality evaluation of ginsenoside reference substances based on qNMR spectroscopy[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2022, 47(3): 575-580.
[16] SAITO T, IHARA T, KOIKE M, et al.A new traceability scheme for the development of international systemtraceable persistent organic pollutant reference materials by quantitative nuclear magnetic resonance[J]. Accredit Qual Assur, 2009, 14(2): 79-86.
[17] WESTWOOD S, YAMAZAKI T, HUANG T, et al.Development and validation of a suite of standards for the purity assignment of organic compounds by quantitative NMR spectroscopy[J]. Metrologia, 2019, 56(6): 1-15.
[18] FENG YX, WU XF, XIAO XY.Determination of moxifloxacin hydrochloride and itr the purity assignment of organic compounds by quantitative NM injectioquinolin ecarboxylic acid by 1H qNMR[J]. Chin J New Drugs(中国新药杂志), 2021, 30(4): 357-361.
[19] LIANG L N, ZHANG X Q, LI S, et al.Determination of content of dextromethorphan hydrobromide tablets based on quantitative proton nuclear magnetic resonance[J]. Chinese Journal of Modern Applied Pharmacy(中国现代应用药学), 2020, 37(3): 304-307.
[20] YANG DZ, WANG FF, ZHANG L, et al.Development of a new ferulic acid certifified reference material for use in clinical chemistry and pharmaceutical analysis[J]. Acta Pharmaceutica Sinica B, 2015, 5(3): 231-237.
[21] CHENG J, LI MH, YU KZ, et al.Identication of peral powder and conch powder from different origins by differential scanning calorimetry[J]. China Journal of Chinese Materia Medica(中国中药杂志), 2015, 40(8): 1459-1462.
[22] LIU J, YANG L, FANG L.Applications and advances of differential scanning calorimetry in pharmaceutics[J]. Chinese Journal of Pharmaceutics(中国药剂学杂志), 2017, 15(5): 119-127.
[23] ZHU J, WU JM, HUANG HW, et al.Research progress of differential scanning calorimetry in drug testing[J]. Chinese Pharmaceutical Affairs(中国药事), 2018, 32(2): 210-215.
[24] ZHOU JY, HUANG YJ, BAI YC, et al.Determination of purity of Lindane by differential scanning calorimetry and mass balance[J]. Journal of Food Safey and Quality(食品安全质量检测学报), 2018, 9(15): 3932-3937.
[25] LIU Y, WU JM, LU J, et al.Application of differential scanning calorimetry in the purity analysis of chemical reference substances[J]. Chinese Journal of New Drugs(中国新药杂志), 2017, 26(10): 1115-1118.
[26] LIN L, NING BM, YANG LH, et al.Application of thermal analysis for drug control[J]. Chinese Journal of New Drugs(中国新药杂志), 2014, 23(15): 1734-1737.
[27] MA K, WANG HF, ZHAO M, et al.Purity determination and uncertainty evaluation of theophylline by mass balance method, high performance liquid chromatography and differential scanning calorimetry[J]. Analytica Chimica Acta, 2009, 227-233.
[28] LI XJ, ZHANG W, LI X, et al.Purity assessment of dinotefuran using mass balance and quantitative nuclear magnetic resonance[J]. Molecules, 2023, 28, 3884.
[29] Consultative Committee for Amount of Substance Eds. Report of 1 st Meeting of CCQM[C]. Paris: The Publishing Unit Unknown, 1995.
[30] WU B, CHENG QY, XIANG PF.Determination the purity of Benzoic acid by high precision constant current coulometry[J]. Modern Instruments(现代仪器与医疗), 2013, 19(2): 64-66.
[31] CHANG ZD, FAN Y, DONG XY.Application of gravimetric analysis in material determination[J]. Industrial Measurement(工业计量), 2015, S2: 13-15.
[32] SUN QY, LYU DY, GAO J, et al.Development of nitrite nitrogen solution reference material[J]. Chemical Analysis and Meterage(化学分析计量), 2022, 31(2): 7-11.
[33] ZHAO H, HAO SJ, LIU YD, et al.Primary method and its application of characterization of reference materials[J]. Chemical Analysis and Meterage(化学分析计量), 2018, 27(Z1): 101-104.
[34] China Association for Instrumental Analysis. Review of CAIA Awards[C]. Beijing: Beijing Science and Technology Press, 2015.
[35] LU KH, ZHANG ZC, ZHANG YP.Research development of purity evaluation technique of high-purity organic compounds based on freezing point depression[J]. Chemical Analysis and Meterage(化学分析计量), 2017, 26(2): 110-114.
[36] ZHAO M, SONG W.Freezing point descent method -a standard method for determining the purity of high-purity organic compounds[J]. China Metrology(中国计量), 2002, 1: 47.
[37] DONG YL, QIAO YS, HUAGN CF, et al.Determination of 6 analgesic drugs in cosmetics by ultra-high performance liquid chromatography–tandem mass spectrometry[J]. Journal of Instrumental Analysis(分析测试学报), 2022, 41(2): 220-226.
[38] CEHN LJ, LI WH, CAI AH, et al.Methodology study on the determination of acetate ions in hemodialysis concentrates by ion chromatography[J]. China Food and Drug(中国食品药品监管), 2020, 6(10): 70-73.
[39] CHEN X.Study on selection of internal standard element in determination of boron by inductively coupled plasma mass spectrometry[J]. Zhejiang Chemical Industry(浙江化工), 2022, 53(1): 38-41.
[40] LI J, WANG PQ.Simultaneous determination of calcium and zinc ions in calcium and zinc gluconate oral solution by ICP-OES[J]. Drug Standards of China(中国药品标准), 2021, 22(4): 356-359.
[41] ZHANG YY.Determination of aluminum, calcium, potassium, lithium, magnesium and sodium in aluminum electrolyte by inductively coupled plasma atomic emission spectrometry[J]. Light Metals(轻金属), 2019, 4: 50-53.
[42] MANG K, SU FH, WANG HF, et al.Progress on certified technique for chemical purity of organic reference material[J]. Journal of Instrumental Analysis(分析测试学报), 2013, 32(7): 901-908.
[43] YAO SC, FENG YC, ZHANG X, et al.Research and development strategy and prospect of anti-infective drug impurity reference substance[J]. Chinese Journal of Antibiotics(中国抗生素杂志), 2022, 47(2): 122-127.