• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
AN Jiong, LI Kan, XU Xiaoming, GAO Zhun, HU Chao, LI Bo, DI Bin, XU Lili. Development and validation of a novel and simple RP-HPLC method for the determination of related substances of tiopronin for injection[J]. Journal of China Pharmaceutical University, 2019, 50(3): 317-324. DOI: 10.11665/j.issn.1000-5048.20190307
Citation: AN Jiong, LI Kan, XU Xiaoming, GAO Zhun, HU Chao, LI Bo, DI Bin, XU Lili. Development and validation of a novel and simple RP-HPLC method for the determination of related substances of tiopronin for injection[J]. Journal of China Pharmaceutical University, 2019, 50(3): 317-324. DOI: 10.11665/j.issn.1000-5048.20190307

Development and validation of a novel and simple RP-HPLC method for the determination of related substances of tiopronin for injection

More Information
  • In this paper, a novel and simple RP-HPLC method for the determination of related substances of tiopronin for injection was described. The RP-HPLC analysis was performed on a C18 column, with acetonitrile-0. 1% phosphoric acid(8 ∶92), mobile phase in isocratic mode at a rate of 1. 0 mL/min. The photodiode array detector was set at 210 nm. Seven related substances were detected and the structures were characterized by mass spectrometry. The method showed great suitability, specificity and excellent linearity over the concentration range of 0. 3 to 50 μg/mL(r≥0. 999), and the limits of detection and quantitation were found to be 0. 10 and 0. 31 μg/mL, respectively. The accuracy of the method determined by the entire mean recovery ranged from 98. 7% to 103. 7%. The intra-and inter-day precision was satisfactory(RSD≤4. 4%)and robust(RSD≤6. 4%). And this method was successfully applied for the determination of related substances of tiopronin for injection, which revealed the retention of sulfhydryl compounds and glycine analogues on the RP-HPLC and the effect of the pH value of the mobile phase on the chromatographic behavior of the analytes.
  • [1]
    Wang JQ,Zou YH,Huang C,et al.Protective effects of tiopronin against high fat diet-induced non-alcoholic steatohepatitis in rats[J].Acta Pharmacol Sin,2012,33(6):791-797.
    [2]
    Tasic V,Lozanovski VJ,Ristoska-Bojkovska N,et al.Nephrotic syndrome occurring during tiopronin treatment for cystinuria[J].Eur J Pediatr,2011,170(2):247-249.
    [3]
    Amor B,Mery C,De GA.Tiopronin(N-[2-mercaptopropionyl] glycin)in rheumatoid arthritis[J].Arthritis Rheum,2014,25(6):698-703.
    [4]
    Ichikawa H,Imaizumi K,Tazawa Y,et al.Effect of tiopronin on senile cataracts[J].Ophthalmologica,1980,180(5):293-298.
    [5]
    Zhang JG,Viale M,Esposito M,et al.Tiopronin protects against the nephrotoxicity of cisplatin in the rat[J].Hum Exp Toxicol,1999,18(12):713-717.
    [6]
    Tomás Pérez-Ruiz, Martínez-Lozano C, Baeyens WRG, et al.Determination of tiopronin in pharmaceuticals using a chemiluminescent flow-injection method[J].J Pharm Biomed Anal,1998,17(4/5):823-828.
    [7]
    Devi PU,Saini MR,Saharan BR,et al.Radioprotective effect of 2-mercaptopropionylglycine on the intestinal crypt of Swiss albino mice after Cobalt-60 irradiation[J].Radiat Res,1979,80(1):214-220.
    [8]
    Kurumaji Y,Miyazaki K.Tiopronin-induced lichenoid eruption in a patient with liver disease and positive patch test reaction to drugs with sulfhydryl group[J].J Dermatol,1990,17(3):176-181.
    [9]
    Kurosaki M,Takagi H,Mori M.HLA-A33/B44/DR6 is highly related to intrahepatic cholestasis inducedby tiopronin[J].Digest Dis Sci,2000,45(6):1103-1108.
    [10]
    Shichiri M.Primary biliary cirrhosis:a patient with adverse reactions to tiopronin and autoimmune hemolyticanemia with reticulocytopenia[J].Arch Intern Med, 1984,144(1):89-91.
    [11]
    Ding XL,Lei ZB.Literature review of 38 cases with tiopronininduced anaphylatic shock[J].Adverse Drug React J(药物不良反应杂志),2005(5):336-339.
    [12]
    Leroy P,Nicolas A,Gavriloff C,et al.Determination of 2-mercaptopropionylglycine and its metabolite,2-mercaptopropionic acid,in plasma by ion-pair reversed-phase high-performance liquid chromatography with post-column derivatization[J].J Chromatogr B,1991,564(1):258-265.
    [13]
    Wang B, Zhao L, Wang H, et al. Determination of tiopronin in human plasma and pharmacokinetics by LC-ESI-MS[J].Chromatographia,2009,70(1/2):89-94.
    [14]
    Matsuura K,Takashina H.Gas chromatographic-mass spectrometric determination of tiopronin in human blood using acrylic acid esters as a derivatization reagent for the thiol group[J].J Chromatogr B,1993,616(2):229-234.
    [15]
    Xu J,Cai R,Wang J,et al.Fluorometric assay of tiopronin based on inhibition of multienzyme redox system[J].J Pharm Biomed Anal,2005,39(1/2):334-338.
    [16]
    Murillo Pulgarín,José A,Lemus Gallego,et al.Determination of tiopronin in pharmatceutical preparations by time resolved chemiluminescence using the stopped-flow technique[J].Anal Lett,2013,46(11):1836-1848.
    [17]
    Li Q,Gao L.Spectrophotometric determination of tiopronin using its catalytic reaction between sodium 1,2-naphthoquinone-4-sulfonate and hydroxyl ion[J].Anal Sci,2009,25(1):89-93.
    [18]
    Casassas E,Ariño C,Esteban M,et al.Analytical determination of N-(2-mercapto propionyl)glycine(tiopronin)by voltammetric methods[J].Anal Lett,2006,24(7):1183-1199.
    [19]
    Nelson D, Cox M. Lehninger principles of biochemistry(4th Ed.)[J].Biochem Mol Biol Edu,2005,33(1):74-75.
  • Related Articles

    [1]GUO Jiru, QIN Chunjun, HU Jing, CAO Xin, XU Yongxue, LIU Jiankai, YIN Jian. Quantitative determination of capsular polysaccharide, C-polysaccharide, phosphorus of carbohydrate antigens from Streptococcus pneumoniae by quantitative NMR using a single internal standard[J]. Journal of China Pharmaceutical University, 2024, 55(4): 472-477. DOI: 10.11665/j.issn.1000-5048.2024020502
    [2]YAO Jian, SHAO Lei, CHEN Daijie, ZHANG Yubin. Transcriptomic analysis of a spiramycin I-resistant Staphylococcus aureus mutant[J]. Journal of China Pharmaceutical University, 2017, 48(6): 738-744. DOI: 10.11665/j.issn.1000-5048.20170617
    [3]XING Ming-xun, JIA Sheng-mei, YUAN Peng, SHI Qi-yun, CHENG Wei, JIN Kun-qi, YU Lu. Inhibition of azithromycin on biofilms of Staphylococcus aureus[J]. Journal of China Pharmaceutical University, 2012, 43(6): 553-559.
    [4]Properties and Type Determinations of Exopenicillinases from Staphylococcus aureus[J]. Journal of China Pharmaceutical University, 1995, (3): 183-186.
    [5]Action of Cell-Bound Penicillinase in Mediating Resistance of Staphylococcus aureus[J]. Journal of China Pharmaceutical University, 1991, (6): 363-366.
    [6]Protoplast-Dependent Plasmid Elimination of Staphylococcus Aureus[J]. Journal of China Pharmaceutical University, 1990, (3): 179-181.
    [7]PLASMID ELIMINATION AND TRANSDUCTION OF STAPHYLOCOCCUS AUREUS RN1304 AND ITS ALBUS VARIANT[J]. Journal of China Pharmaceutical University, 1989, (3): 151-154.
    [8]PROPERTIES OF A BETA-LACTAMASE FROM STAPHYLOCOCCUS AUREUS~*[J]. Journal of China Pharmaceutical University, 1988, (1): 38-41.
    [9]EXTRACTION AND DETECTION OF ANTIBIOTIC RESISTANT PLASMID DNA IN STAPHYLOCOCUS AUREUS[J]. Journal of China Pharmaceutical University, 1985, (2): 53-58.
    [10]ELIMINATION OF ANTIBIOTIC RESISTANT PLASMIDS IN STAPHYLOCOCCUS AUREUS[J]. Journal of China Pharmaceutical University, 1985, (2): 48-52.

Catalog

    Article views (809) PDF downloads (953) Cited by()

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return