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

AN Jiong; LI Kan; XU Xiaoming; GAO Zhun; HU Chao; LI Bo; DI Bin; XU Lili

doi:10.11665/j.issn.1000-5048.20190307

Journal of China Pharmaceutical University > 2019 > 50(3): 317-324. > DOI: 10.11665/j.issn.1000-5048.20190307

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:

PDF (1642 KB)

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

AN Jiong¹,
LI Kan¹,
XU Xiaoming¹,
GAO Zhun¹,
HU Chao²,
LI Bo^1,3,
DI Bin^1,3,
XU Lili^1,3

More Information

Graphical Abstract

Abstract

Abstract

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.
- RP-HPLC,
- tiopronin for injection,
- related substances

FullText(HTML)

References (19)

References

[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.

Cited By

Cited by

Periodical cited type(3)

1.	王燚，秦冬玲，孙琴. 基于银纳米片的形貌定向演化比色检测药物硫普罗宁. 重庆师范大学学报(自然科学版). 2024(04): 42-49 .
2.	孙双姣，何芳，邓子璇. 基于罗丹明B的荧光探针“关-开”法测定硫普罗宁的含量. 邵阳学院学报(自然科学版). 2023(05): 62-68 .
3.	林瑜，李见能，韦小玲，潘真真，李芳婵，谭建宁. 紫外-可见分光光度法间接测定硫普罗宁的含量. 理化检验-化学分册. 2022(10): 1194-1198 .

Other cited types(0)

Get Citation

PDF

XML

Article views (815) PDF downloads (953) Cited by(3)

Turn off MathJax

Article Contents

Abstract

References

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

Abstract

References

Cited by

Periodical cited type(3)

Other cited types(0)

Catalog

Export File

Citation

Format

Content