Overview of the research on drug impurity

LI Na; LOU Ziyang

doi:10.3969/j.issn.1006-0111.2014.03.005

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Article Navigation > Journal of Pharmaceutical Practice and Service > 2014 > 32(3): 179-185

LI Na, LOU Ziyang. Overview of the research on drug impurity[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005

Citation:

LI Na, LOU Ziyang. Overview of the research on drug impurity[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(3): 179-185. doi: 10.3969/j.issn.1006-0111.2014.03.005

Overview of the research on drug impurity

doi: 10.3969/j.issn.1006-0111.2014.03.005

LI Na,
LOU Ziyang

School of Pharmacy, Second Military Medical University, Shanghai 200433, China

Received Date: 2013-11-06
Rev Recd Date: 2014-01-16

Abstract

As special commodities, drugs had closely relationships with human beings' health and life safety. Impurity, which would influence the stability and efficacy of drugs, was closely related to the quality, safety and efficacy of drugs. With more and more attendance had been attached to the impurity's control in the development of drugs, researchers turned their attentions to the analysis of trace impurity. In this paper, related progresses in recent 10 years were summarized, including guiding principles in impurity research, technologies in qualitative research and general approaches in quantitative research.
- impurity,
- guiding principles,
- research technologies,
- review

References

[1]	国家食品药品监督管理局. 化学药物杂质研究的技术指导原则[S]. 2005.
[2]	Available from: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.
[3]	McMahon AW, Pratt RG, Hammad TA. Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008[J]. Pharm Epidemiol Drug Saf,2010,19(9): 921-933.
[4]	Müller L, Mauthe RJ, Riley CM. A rationale for determining,testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity[J]. Regul Toxicol Pharmacol. 2006,44(3): 198-211.
[5]	http://www.cde.org.cn/dzkw.do?method=largePage&id=311390.
[6]	国家药典委员会.中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录205.
[7]	Görög S. Identification and determination of impurities in drugs[M]. Amsterdam (Netherlands): Elsevier Science,2000:506-547.
[8]	Pavón JLP, M.del NS, Laespada MEF. Analysis of class 1 residual solvents in pharmaceuticals using headspace-programmed temperature vaporization-fast gas chromatography-mass spectrometry[J]. J Chromatogr A,2007,1141(1): 123-130.
[9]	Saavedra L, Huidobro AL, García A. CE as orthogonal technique to HPLC for alprazolam degradation product identification[J]. Electrophoresis, 2006,27(12):2360-2366.
[10]	Wang X, Li W, Rasmussen HT. Orthogonal method development using hydrophilic interaction chromatography and reversed-phase high-performance liquid chromatography for the determination of pharmaceuticals and impurities[J]. J Chromatogr A, 2005,1083(1-2):58-62.
[11]	Slonecker PJ, Li X, Ridgway TH. Informational orthogonality of two-dimensional chromatographic separations[J]. Anal Chem, 1996,68(4): 682-689.
[12]	Cheng JYK, Chan MF, Chan TW. Impurity profiling of ecstasy tablets seized in Hong Kong by gas chromatography-mass spectrometry[J]. Forensic Sci Int, 2006,162(1-3): 87-94.
[13]	Bonadio F, Margot P, Delémont O. Optimization of HS-SPME/GC-MS analysis and its use in the profiling of illicit ecstasy tablets (Part 1)[J]. Forens Sci Int,2009,187(1-3): 73-80.
[14]	任丽萍, 田芹, 潘灿平. 丁草胺原药中主要杂质的GC-MS定性分析[J]. 农药(Chinese Journal of Pesticides). 2005: 44(4): 74-78.
[15]	Chen W, Zhou P, Moon KCW. Identification of volatile degradants in formulations containing sesame oil using SPME/GC/MS[J]. J Pharm.Biomed.Anal.,2007,44(2): 450-455.
[16]	Łaniewsk K, Wannman T, Hagman G. Gas chromatography with mass spectrometric, atomic emission and fourier transform infrared spectroscopic detection as complementary analytical techniques for the identification of unknown impurities in pharmaceutical analysis[J]. J Chromatogr A, 2003,985(1-2): 275-282.
[17]	Łaniewsk K, VågeröM, Forsberg E. Complementary use of gas chromatography-mass spectrometry, gas chromatography-atomic emission detection and nuclear magnetic resonance for identification of pharmaceutically related impurities of unknown structures[J]. J Chromatogr A, 2004,1027(1-2):93-102.
[18]	Bedse G, Kumar V, Singh S. Study of forced decomposition behavior of lamivudine using LC, LC-MS/TOF and MSn[J]. J Pharm Biomed Anal,2009,49(1): 55-63.
[19]	Modhave D.T, Handa T, Shah RP. Successful characterization of degradation products of drugs using LC-MS tools: application to piroxicam and meloxicam[J]. Anal Methods,2011,3(12): 2864-2872.
[20]	Modhave DT, Handa T, Shah RP. Stress degradation studies on lornoxicam using LC, LC-MS/TOF and LC-MSn[J]. J Pharm Biomed Anal,2011,56(3): 538-545.
[21]	Shah RP, Singh S. Identification and characterization of a photolytic degradation product of telmisartan using LC-MS/TOF, LC-MSn, LC-NMR and on-line H/D exchange mass studies[J]. J Pharm.Biomed Anal,2010,53(3): 755-761.
[22]	Wang MJ, Pendela M, Hu CQ. Impurity profiling of acetylspiramycin by liquid chromatography-ion trap mass spectrometry[J]. J Chromatogr A, 2010, 1217(42): 6531-6544.
[23]	Mehta S, Shah RP, Priyadarshi R. LC and LC-MS/TOF studies on stress degradation behaviour of candesartan cilexetil[J]. J Pharm Biomed Anal,2010,52(3): 345-354.
[24]	Liu DQ, Wu L, Sun M. On-line H/D exchange LC-MS strategy for structural elucidation of pharmaceutical impurities[J]. J Pharm Biomed.Anal,2007,44(2): 320-329.
[25]	Shah RP, Sahu A, Singh S. Identification and characterization of degradation products of irbesartan using LC-MS/TOF, MSn, on-line H/D exchange and LC-NMR[J]. J Pharm Biomed Anal,2010,51(5): 1037-1046.
[26]	Thurman EM, Ferrer I. The isotopic mass defect: a tool for limiting molecular formulas by accurate mass[J]. Anal Bioanal Chem, 2010,397(7): 2807-2816.
[27]	Bertinatto JA, Rodr'ıguez, Desimone MF. Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities[J]. J Pharm Biomed Anal,2007,44(1): 305-308.
[28]	Wijk AMv, Muijselaar PG, Stegman K. Capillary electrophoresis-mass spectrometry for impurity profiling of basic pharmaceuticals using non-volatile background electrolytes[J]. J Chromatogr A,2007,1159(1-2): 175-184.
[29]	Mol R, Kragt E, Jimidar I. Micellar electrokinetic chromate graphy-electrospray ionization mass spectrometry for the identification of drug impurities[J]. J Chromatogr B,2006,843(2): 283-288.
[30]	Hernández SL,Ruiz GC, Crego AL. Sensitive determination of D-carnitine as enantiomeric impurity of levo-carnitine in pharmaceutical formulations by capillary electrophoresis-tandem mass spectrometry[J]. J Pharm Biomed Anal,2010,53(5): 1217-1223.
[31]	Carvalho AZ, Attug EMN, Zayed SE. Micellar electrokinetic chromatography method development for determination of impurities in ritonavir[J]. J Pharm Biomed Anal,2010,53(5): 1210-1216.
[32]	Görög S. Identification and Determination of Impurities in Drugs[M].Amsterdam:Elsevier Science, 2000:67-82.
[33]	Murakami T, Konno H, Fukutsu N. Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques[J]. J Pharm Biomed Anal, 2008,47(3):553-559.
[34]	Wolters AM, Jayawickrama DA, Larive CK. Capillary isotachophoresis/NMR: extension to trace impurity analysis and improved instrumental coupling[J]. Anal Chem, 2002,74(10): 2306-2313.
[35]	Prabha Srinivasu, Devarakonda V, SubbaRao A. validated stabilityúindicating LC method for acetazolamide in the presence of degradation products and its process-related impurities[J]. J Pharm Biomed Anal., 2011, 52(1):142-148.
[36]	Székely Gy, Henriques B, Gil M. Design of experiments as a tool for LC-MS/MS method development for the trace analysis of the potentially genotoxic 4-dimethy laminopyridine impurity in glucocorticoids[J]. J Pharm Biomed Anal, 2012,70:251-258.
[37]	徐宜宏,蒋施,付海滨,等.气相色谱-三重四极杆质谱法同时测定五味子中117种农药残留量[J]. 福建分析测试,2012,21(5):1-10.

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通讯作者: 陈斌, bchen63@163.com

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沈阳化工大学材料科学与工程学院沈阳 110142

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Overview of the research on drug impurity

School of Pharmacy, Second Military Medical University, Shanghai 200433, China

Received Date: 2013-11-06

Rev Recd Date: 2014-01-16

Key words:

Abstract: As special commodities, drugs had closely relationships with human beings' health and life safety. Impurity, which would influence the stability and efficacy of drugs, was closely related to the quality, safety and efficacy of drugs. With more and more attendance had been attached to the impurity's control in the development of drugs, researchers turned their attentions to the analysis of trace impurity. In this paper, related progresses in recent 10 years were summarized, including guiding principles in impurity research, technologies in qualitative research and general approaches in quantitative research.

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Reference (37)

[1]	国家食品药品监督管理局. 化学药物杂质研究的技术指导原则[S]. 2005.
[2]	Available from: http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm.
[3]	McMahon AW, Pratt RG, Hammad TA. Description of hypersensitivity adverse events following administration of heparin that was potentially contaminated with oversulfated chondroitin sulfate in early 2008[J]. Pharm Epidemiol Drug Saf,2010,19(9): 921-933.
[4]	Müller L, Mauthe RJ, Riley CM. A rationale for determining,testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity[J]. Regul Toxicol Pharmacol. 2006,44(3): 198-211.
[5]	http://www.cde.org.cn/dzkw.do?method=largePage&id=311390.
[6]	国家药典委员会.中华人民共和国药典2010年版二部[S].北京:中国医药科技出版社,2010:附录205.
[7]	Görög S. Identification and determination of impurities in drugs[M]. Amsterdam (Netherlands): Elsevier Science,2000:506-547.
[8]	Pavón JLP, M.del NS, Laespada MEF. Analysis of class 1 residual solvents in pharmaceuticals using headspace-programmed temperature vaporization-fast gas chromatography-mass spectrometry[J]. J Chromatogr A,2007,1141(1): 123-130.
[9]	Saavedra L, Huidobro AL, García A. CE as orthogonal technique to HPLC for alprazolam degradation product identification[J]. Electrophoresis, 2006,27(12):2360-2366.
[10]	Wang X, Li W, Rasmussen HT. Orthogonal method development using hydrophilic interaction chromatography and reversed-phase high-performance liquid chromatography for the determination of pharmaceuticals and impurities[J]. J Chromatogr A, 2005,1083(1-2):58-62.
[11]	Slonecker PJ, Li X, Ridgway TH. Informational orthogonality of two-dimensional chromatographic separations[J]. Anal Chem, 1996,68(4): 682-689.
[12]	Cheng JYK, Chan MF, Chan TW. Impurity profiling of ecstasy tablets seized in Hong Kong by gas chromatography-mass spectrometry[J]. Forensic Sci Int, 2006,162(1-3): 87-94.
[13]	Bonadio F, Margot P, Delémont O. Optimization of HS-SPME/GC-MS analysis and its use in the profiling of illicit ecstasy tablets (Part 1)[J]. Forens Sci Int,2009,187(1-3): 73-80.
[14]	任丽萍, 田芹, 潘灿平. 丁草胺原药中主要杂质的GC-MS定性分析[J]. 农药(Chinese Journal of Pesticides). 2005: 44(4): 74-78.
[15]	Chen W, Zhou P, Moon KCW. Identification of volatile degradants in formulations containing sesame oil using SPME/GC/MS[J]. J Pharm.Biomed.Anal.,2007,44(2): 450-455.
[16]	Łaniewsk K, Wannman T, Hagman G. Gas chromatography with mass spectrometric, atomic emission and fourier transform infrared spectroscopic detection as complementary analytical techniques for the identification of unknown impurities in pharmaceutical analysis[J]. J Chromatogr A, 2003,985(1-2): 275-282.
[17]	Łaniewsk K, VågeröM, Forsberg E. Complementary use of gas chromatography-mass spectrometry, gas chromatography-atomic emission detection and nuclear magnetic resonance for identification of pharmaceutically related impurities of unknown structures[J]. J Chromatogr A, 2004,1027(1-2):93-102.
[18]	Bedse G, Kumar V, Singh S. Study of forced decomposition behavior of lamivudine using LC, LC-MS/TOF and MSn[J]. J Pharm Biomed Anal,2009,49(1): 55-63.
[19]	Modhave D.T, Handa T, Shah RP. Successful characterization of degradation products of drugs using LC-MS tools: application to piroxicam and meloxicam[J]. Anal Methods,2011,3(12): 2864-2872.
[20]	Modhave DT, Handa T, Shah RP. Stress degradation studies on lornoxicam using LC, LC-MS/TOF and LC-MSn[J]. J Pharm Biomed Anal,2011,56(3): 538-545.
[21]	Shah RP, Singh S. Identification and characterization of a photolytic degradation product of telmisartan using LC-MS/TOF, LC-MSn, LC-NMR and on-line H/D exchange mass studies[J]. J Pharm.Biomed Anal,2010,53(3): 755-761.
[22]	Wang MJ, Pendela M, Hu CQ. Impurity profiling of acetylspiramycin by liquid chromatography-ion trap mass spectrometry[J]. J Chromatogr A, 2010, 1217(42): 6531-6544.
[23]	Mehta S, Shah RP, Priyadarshi R. LC and LC-MS/TOF studies on stress degradation behaviour of candesartan cilexetil[J]. J Pharm Biomed Anal,2010,52(3): 345-354.
[24]	Liu DQ, Wu L, Sun M. On-line H/D exchange LC-MS strategy for structural elucidation of pharmaceutical impurities[J]. J Pharm Biomed.Anal,2007,44(2): 320-329.
[25]	Shah RP, Sahu A, Singh S. Identification and characterization of degradation products of irbesartan using LC-MS/TOF, MSn, on-line H/D exchange and LC-NMR[J]. J Pharm Biomed Anal,2010,51(5): 1037-1046.
[26]	Thurman EM, Ferrer I. The isotopic mass defect: a tool for limiting molecular formulas by accurate mass[J]. Anal Bioanal Chem, 2010,397(7): 2807-2816.
[27]	Bertinatto JA, Rodr'ıguez, Desimone MF. Validation of a capillary electrophoresis method for the analysis of ibandronate related impurities[J]. J Pharm Biomed Anal,2007,44(1): 305-308.
[28]	Wijk AMv, Muijselaar PG, Stegman K. Capillary electrophoresis-mass spectrometry for impurity profiling of basic pharmaceuticals using non-volatile background electrolytes[J]. J Chromatogr A,2007,1159(1-2): 175-184.
[29]	Mol R, Kragt E, Jimidar I. Micellar electrokinetic chromate graphy-electrospray ionization mass spectrometry for the identification of drug impurities[J]. J Chromatogr B,2006,843(2): 283-288.
[30]	Hernández SL,Ruiz GC, Crego AL. Sensitive determination of D-carnitine as enantiomeric impurity of levo-carnitine in pharmaceutical formulations by capillary electrophoresis-tandem mass spectrometry[J]. J Pharm Biomed Anal,2010,53(5): 1217-1223.
[31]	Carvalho AZ, Attug EMN, Zayed SE. Micellar electrokinetic chromatography method development for determination of impurities in ritonavir[J]. J Pharm Biomed Anal,2010,53(5): 1210-1216.
[32]	Görög S. Identification and Determination of Impurities in Drugs[M].Amsterdam:Elsevier Science, 2000:67-82.
[33]	Murakami T, Konno H, Fukutsu N. Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques[J]. J Pharm Biomed Anal, 2008,47(3):553-559.
[34]	Wolters AM, Jayawickrama DA, Larive CK. Capillary isotachophoresis/NMR: extension to trace impurity analysis and improved instrumental coupling[J]. Anal Chem, 2002,74(10): 2306-2313.
[35]	Prabha Srinivasu, Devarakonda V, SubbaRao A. validated stabilityúindicating LC method for acetazolamide in the presence of degradation products and its process-related impurities[J]. J Pharm Biomed Anal., 2011, 52(1):142-148.
[36]	Székely Gy, Henriques B, Gil M. Design of experiments as a tool for LC-MS/MS method development for the trace analysis of the potentially genotoxic 4-dimethy laminopyridine impurity in glucocorticoids[J]. J Pharm Biomed Anal, 2012,70:251-258.
[37]	徐宜宏,蒋施,付海滨,等.气相色谱-三重四极杆质谱法同时测定五味子中117种农药残留量[J]. 福建分析测试,2012,21(5):1-10.

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Overview of the research on drug impurity

doi: 10.3969/j.issn.1006-0111.2014.03.005

Abstract

References

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通讯作者: 陈斌, bchen63@163.com

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