The use of atomic spectroscopy in the pharmaceutical industry for the determination of trace elements in pharmaceuticals

Journal of Pharmaceutical and Biomedical Analysis

Volumn 55, Issue 4, 2011, Pages 653-661

  Lewen, Nancy ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Atomic spectroscopy; Elements; EMEA; Pharmaceuticals; USP

Indexed keywords

ENALAPRIL MALEATE; FOLINATE CALCIUM; LEVODOPA; METHAMPHETAMINE;

ATOMIC ABSORPTION SPECTROMETRY; CATHODE RAY TUBE; DRUG INDUSTRY; LASER SURGERY; MASS SPECTROMETRY; PRIORITY JOURNAL; RAMAN SPECTROMETRY; REVIEW;

CHEMISTRY TECHNIQUES, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; COLD TEMPERATURE; DRUG INDUSTRY; LASERS; METALS; PHARMACEUTICAL PREPARATIONS; SPECTROPHOTOMETRY, ATOMIC; SPECTRUM ANALYSIS; TRACE ELEMENTS;

EID: 79955463063     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.11.030     Document Type: Review

References (74)

1. Pearce J.M.S. Burton's line in lead poisoning. Eur. Neurol. 2007, 57:118-119.
2. Zhao H.L., Zhu X., Sui Y. Letters to the Editor: The short-lived Chinese emperors. J. Am. Geriatric. Soc. 2006, 54:1295-1296.
3. Pharmacopoeia of the United States of America Procedure 121, Time-limit test for heavy elements, 8th revision 1905, Lippincott, Philadelphia, PA.
4. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, 2009. Chapter 231, Heavy Elements, pp. 134-136.
5. Abernethy D., DeStefano A., Cecil T., Zaidi K., Williams R. the USP Metal Impurities Advisory Panel. Metal Impurities in Food and Drugs. Pharm. Res. 2010, 27:750-755.
6. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, 2009. Chapter 241, Iron, pp. 2557-2558.
7. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, 2009, Chapter 251, Lead, pp. 2558-2559.
8. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, Chapter 261, Mercury, 2009, pp. 2558-2560.
9. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, Chapter 291, Selenium, 2009, pp. 2560-2561.
10. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, Chapter 591, Zinc, 2009, p. 2616.
11. The United States Pharmacopeia/The National Formulary, USP 32/NF 27. The United States Pharmacopeial Convention, Rockville, MD, 2009. Chapter 206, Aluminum, pp. 2554-2555.
12. The United States Pharmacopeia/The National Formulary, USP 32/NF 27. The United States Pharmacopeial Convention, Rockville, MD, 2009, Chapter 191, Identification Tests-General, pp. 2550-2551.
13. Lewen N., Nugent D. The use of inductively coupled plasma-atomic emission spectroscopy (ICP-AES) in the determination of lithium in cleaning validation swabs. J. Pharm. Biomed. Anal. 2010, 52:652-655.
14. Lewen N., Mathew S., Schenkenberger M., Raglione T. A rapid ICP-MS screen for heavy elements in pharmaceutical compounds. J. Pharm. Biomed. Anal. 2004, 35:739-752.
15. Wang T., Wu J., Hartman R., Jia X., Eagan R. A multi-element ICP-MS survey method as an alternative to the heavy elements limit test for pharmaceutical materials. J. Pharm. Biomed. Anal. 2000, 23:867-890.
16. Lewen N. The application of several atomic spectroscopy techniques in a pharmaceutical analytical research and development laboratory. Spectroscopy 1997, 12:14-23.
17. Lewen N., Schenkenberger M., Larkin T., Conder S., Brittain H. The determination of palladium in fosinopril sodium (monopril) by ICP-MS. J. Pharm. Biomed. Anal. 1995, 13:879-883.
18. Duffus J. Heavy metals-a meaningless term?. Pure Appl. Chem. 2002, 74:793-807.
19. European Medicines Agency, Doc. Ref. EMEA/CHMP/SWP/4446/2000, London, 21 February 2008.
20. USP Elemental impurities-limits 232. Pharm. Forum 2010, 36:197-200.
21. USP Elemental impurities-procedures. Pharm. Forum 2010, 36:201-207.
22. USP Elemental impurities-information. Pharm. Forum 2010, 36:298-305.
23. Beauchemin D. Inductively Coupled Plasma Mass Spectrometry. Anal. Chem. 2006, 78:4111-413524.
24. Wang T., Ge Z., Wu J., Li B., Liang A. Determination of tungsten in bulk drug substance and intermediates by ICP-AES and ICP-MS. J. Pharm. Biomed. Anal. 1999, 19:937-943.
25. Huang J., Hu X., Zhang J., Li K., Yan Y., Xu X. The application of inductively coupled plasma mass spectrometry in pharmaceutical and biomedical analysis. J. Pharm. Biomed. Anal. 2006, 40:227-234.
26. Rao R., Kumar Talluri M.V.N. An overview of recent applications of inductively coupled plasma-mass spectrometry (ICP-MS) in determination of inorganic impurities in drugs and pharmaceuticals. J. Pharm. Biomed. Anal. 2007, 45:1-13.
27. St-Onge L., Kwong E., Sabsabi M., Vadas E.B. Quantitative analysis of pharmaceutical products by laser-induced breakdown spectroscopy. Spectrochim. Acta B 2002, 57:1131-1140.
28. Watling R.J. Sourcing the provenance of cannabis crops using inter-element association patterns " fingerprinting" and laser ablation inductively coupled plasma mass spectrometry. J. Anal. At. Spectrom. 1998, 13:917-926.
29. Willard H.H., Merritt L.L., Dean J.A. Instrumental Methods of Analysis 1974, D. Van Nostrand Company, New York, p. 354. 5th edition.
30. Slavin W. Graphite Furnace AAS A Source Book 1984, The Perkin-Elmer Corporation, Norwalk, CT, pp. 1-6.
31. M. Wassall, Improving background correction capabilities in GFAAS, American Laboratory, February, 1994, 48JJJ-48MMM.
32. Date A.R., Gray A.L. Applications of Inductively Coupled Plasma Mass Spectrometry 1989, Chapman and Hall, New York.
33. Thiem T.L. Comparison of Optical Emission/Mass Spectroscopy Utilizing Laser Vaporization of Solid Samples for Inorganic Analysis February 1994, American Laboratory, pp. 48CCC-48HHH.
34. Torborg C., Beller M. Recent Applications of Palladium-Catalyzed Coupling Reactions in the Pharmaceutical, Agrochemical, and Fine Chemicals Industries. Adv. Synth. Catal. 2009, 351:3027-3043.
35. Jones W.H., Platinum Palladium in the pharmaceutical industry. Platinum Metals Rev. 1958, 2:86-89.
36. Raghavan R., Mulligan J.A. Low-level (ppb) determination of cisplatin in cleaning validations (rinse water) samples. I. An atomic absorption spectrophotometric method. Drug Dev. Ind. Pharm. 2000, 26:423-428.
37. Myors R., Wells R.J., Skopec S.V., Crisp P., Iavetz R., Skopec Z., Ekangaki A., Robertson J. Preliminary investigation of heroin fingerprinting using trace elemental concentrations. Anal. Commun. 1998, 35:403-410.
38. Tu Q., Wang T., Welch C. High-throughput metal screening in pharmaceutical samples by ICP-MS with automated flow injection using a modified HPLC configuration. J. Pharm. Biomed. Anal. 2010, 51:90-95.
39. Welch C., Tu Q., Wang T., Raab C., Wang P., Jia X., Bu X., Bykowski D., Hohenstaufen B., Doyle M. Observations of rhodium-containing reaction intermediates using HPLC with ICP-MS and ESI-MS detection. Adv. Synth. Catal. 2006, 248:821-825.
40. Vergote V., Burvenich C., Van de Wiele C., De Spiegeleer B. Quality specifications for peptide drugs: a regulatory-pharmaceutical approach. J. Pept. Sci. 2009, 15:697-710.
41. Harigaya K., Kuwahara Y., Nishi H. Determination of aluminum in large volume parenteral drug products used in total parenteral nutrition therapy by ICP-MS with a dynamic reaction cell. Chem. Pharm. Bull. 2008, 56:475-479.
42. Santamaria-Fernandez R., Wolff J.-C. Application of laser ablation multicollector inductively coupled plasma mass spectrometry for the measurement of calcium and lead isotope ratios in packaging for discriminatory purposes. Rapid Commun. Mass Spectrom 2010, 24:1993-1999.
43. Zuccarello D.J., Murphy M.P., Meyer R.F., Winslow P.A. A comprehensive approach for the determination of extractable and leachable elements in pharmaceutical products by inductively coupled plasma. PDA J. Pharm. Sci. Tech. 2009, 63:339-352.
44. Zachariadis G.A., Michos C.E. Development of a slurry introduction method for multi-element analysis of antibiotics by inductively coupled plasma atomic emission spectrometry using various types of spray chamber and nebulizer configurations. J. Pharm. Biomed. Anal. 2007, 43:951-958.
45. Mowery M.D., Sing R., Kirsch J., Razaghi A., Béchard S., Reed R.A. Rapid at-line analysis of coating thickness and uniformity on tablets using laser induced breakdown spectroscopy. J. Pharm. Biomed. Anal. 2002, 28:935-943.
46. Wang T., Walden S., Egan R. Development and validation of a general non-digestive method for the determination of palladium in bulk pharmaceuticals and their synthetic intermediates by graphite furnace atomic absorption spectroscopy. J. Pharm. Biomed. Anal. 1997, 15:593-599.
47. The United States Pharmacopeia/The National Formulary, USP 32/NF 27. Chapter 851, Spectrophotometry and Light Scattering. The United States Pharmacopeial Convention, Rockville, MD, 2010, pp. 373-378.
48. Orisakwe O.E., Nduka J.K. Lead and cadmium levels of commonly administered pediatric syrups in Nigera: a public health concern?. Sci. Total Environ. 2009, 47:5993-5996.
49. Sugisawa K., Kaneko T., Sago T., Sato T. Rapid quantitative analysis of magnesium stearate in pharmaceutical powders and solid dosage forms by atomic absorption: method development and application in product manufacturing. J. Pharm. Biomed. Anal. 2009, 49:858-861.
50. Issa M.M., Nejem R.M., Al-Kholy M., El-Abadla N.S., Helles R.S., Saleh A.A. An indirect atomic absorption spectrometric determination of ciprofloxacin, amoxicillin and diclofenac sodium in pharmaceutical formulations. J. Serbe. Chem. Soc. 2008, 75:569-576.
51. The United States Pharmacopeia/The National Formulary, USP 32/NF 27. The United States Pharmacopeial Convention, Rockville, MD, 2010. Chapter 730, General Chapter on Plasma Spectrochemistry, pp. 285-290.
52. Arantes De Carvalho G.G., Nunes L.C., Florencio De Souza P., Krug F.J., Correia Alegre T., Santos D. Evaluation of laser induced breakdown spectroscopy for the determination of macro and micronutrients in pharmaceutical tablets. J. Anal. Atom. Spectrom. 2010, 25:803-809.
53. Madamba M.C., Mullett W.M., Debnath S., Kwong E. Characterization of tablet film coatings using a laser-induced breakdown spectroscopic technique. AAPS Pharm. Sci. Tech. 2007, 8. Article No. 103.
54. St.-Onge L., Archambault J.-F., Kwong E., Sabsabi M., Vadas E.B. Rapid quantitative analysis of magnesium stearate in tablets using laser-induced breakdown spectroscopy. J. Pharm. Pharm. Sci. 2005, 8:272-288.
55. Green R.L., Mowery M.D., Good J.A., Higgins J.P., Arrivo S.M., McColough K., Mateos A., Reed R.A. Comparison of near-infrared and laser-induced breakdown spectroscopy for determination of magnesium stearate in pharmaceutical powders and solid dosage forms. Appl. Spectrosc. 2005, 59:340-357.
56. St.-Onge L., Kwong E., Sabsabi M., Vadas E.B. Rapid analysis of liquid formulations containing sodium chloride using laser-induced breakdown spectroscopy. J. Pharm. Biomed. Anal. 2004, 36:277-284.
57. Jia X., Wang T., Wu J. Determination of palladium by graphite furnace atomic absorption spectroscopy without matrix matching. Talanta 2001, 54:741-751.
58. P. Wilton, Proteins prove their metal, Physorg.com, July 7, 2010, http://www.physorg.com/news197728929.html.
59. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline: Validation of Analytical Procedures: Text and Methodology Q2(R1), November 2005, Geneva, Switzerland.
60. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline: Impurities in New Drug Substances Q3A(R2), October, 2006, Geneva, Switzerland.
61. The United States Pharmacopeia/The National Formulary, USP 32/NF 27, The United States Pharmacopeial Convention, Rockville, MD, 2009. Chapter 1225, Validation of Compendial Procedures, pp. 733-736.
62. Kelkó-Lévai A., Varga I., Zih-Perényi K., Lászity A. Determination of trace elements in pharmaceutical substances by graphite furnace atomic absorption spectrometry and total reflection X-ray fluorescence after flow injection ion-exchange preconcentration. Spectrochim. Acta Part B 1999, 54:827-833.
63. Heinemann G., Vogt W. Vanadium-Contaminated Perioperatively Administered Infusion Solutions and Drugs. Biol. Trace Element Res. 2000, 75:227-234.
64. Axelsson B-O., Jörnten-Karlsson M., Michelsen P., Abou-Shakra F. The potential of inductively coupled plasma mass spectrometry detection for high-performance liquid chromatography combined with accurate mass measurement of organic pharmaceutical compounds. Rapid Commun. Mass Spectrom. 2001, 15:375-385.
65. Zachariadis G., Raidou E.S., Themelis D.G., Stratis J.A. Determination of mineral content of active dry yeast used in pharmaceutical formulations. J. Pharm. Biomed. Anal. 2002, 28:463-473.
66. Resano M., Garcia-Ruiz E., Crespo C., Vanhaecke F., Belarra M.A. Solid sampling-graphite furnace atomic absorption spectrometry for palladium determination at trace and ultratrace levels. J. Anal. Atom. Spectrom. 2003, 18:1477-1484.
67. Kannamkumarath S.S., Wuilloud R.G., Stalcup A., Caruso J.A., Patel H., Sakr A. Determination of levothyroxine and its degradation products in pharmaceutical tablets by HPLC-UV-ICP-MS. J. Anal. Atom. Spectrom. 2004, 19:107-113.
68. Suzuki S., Tsuchihashi H., Nkajima K., Matshushita A., Nagao T. Analysis of impurities in methamphetamine by inductively coupled plasma mass spectrometry and ion chromatography. J. Chromatogr. Sci. 1988, 437:322-327.
69. Evans E.H., Wolff J-C., Eckers C. Sulfur-specific detection of impurities in cimetidine drug substance using liquid chromatography coupled to high resolution inductively coupled plasma mass spectrometry and electrospray mass spectrometry. Anal. Chem. 2001, 73:4722-4728.
70. Lam R., Salin E.D. Analysis of pharmaceutical tablets by laser ablation inductively coupled plasma atomic emission spectrometry and mass spectrometry (LA-ICP-AES and LA-ICP-MS). J. Anal. Atom. Spectrom. 2004, 19:938-940.
71. Figueredo E.C., Dědina J., Arruda M.A.Z. Metal furnace heated by flame as hydride atomizer for atomic absorption spectrometry: Sb determination in environmental and pharmaceutical samples. Talanta 2007, 73:621-628.
72. El Ries M.A., Khalil S. Indirect atomic absorption determination of atropine, diphenhydramine, tolazoline, levamisole based on formation of ion-associates with potassium tetraiodomercurate. J. Pharm. Biomed. Anal. 2001, 25:3-7.
73. Lásztity A., Kelkó-Lévai Á., Varga I., Zih-Perényi K., Bertalan É. Development of atomic spectrometric methods for trace metal analysis of pharmaceuticals. Microchem. J. 2002, 73:59-63.
74. Fliszar K., Walker D., Allain L. Profiling of metal ions leached from pharmaceutical packaging materials. PDA J. Pharm. Sci. Technol. 2006, 60:337-342.