A review on need and importance of impurity profiling

Current Pharmaceutical Analysis

Volumn 7, Issue 1, 2011, Pages 62-70

  Nagpal, Sunny ^a   Karan, ^a   Upadhyay, Ashutosh ^a   Bhardwaj, T R ^a   Thakkar, Arti ^a  

^a ISF COLLEGE OF PHARMACY   (India)

Author keywords

Active pharmaceutical ingredients; Excipients; Forced degradation; ICH guidelines; Impurity profiling; Sources of impurities

Indexed keywords

1,1,1 TRICHOLROETHANE; 1,2 DICHLOROETHANE; 3,4 METHYLENEDIOXYMETHAMPHETAMINE; 4 AMINOPHENOL; ACETONITRILE; ACETYLSALICYLIC ACID; AMPICILLIN; BENZENE; BENZOCAINE; CARBON TETRACHLORIDE; CATECHOLAMINE; CEFOTAXIME; CHLOROBENZENE; CHLOROFORM; CIPROFLOXACIN; CYCLOHEXANE; ERGOMETRINE; ESOMEPRAZOLE; ETHYL PARABEN; ETHYLENE GLYCOL; LEVALBUTEROL; LEVOFLOXACIN; NIFEDIPINE; OFLOXACIN; ORGANIC SOLVENT; PARACETAMOL; PHENOTHIAZINE; RIBOFLAVIN; UNCLASSIFIED DRUG; UNINDEXED DRUG; VINYLIDENE CHLORIDE;

CAPILLARY ELECTROPHORESIS; COLUMN CHROMATOGRAPHY; CRYSTALLIZATION; DRUG DEGRADATION; DRUG FORMULATION; DRUG IMPURITY; DRUG STRUCTURE; FOOD AND DRUG ADMINISTRATION; GAS CHROMATOGRAPHY; HEALTH HAZARD; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INFRARED SPECTROSCOPY; MASS SPECTROMETRY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PHOTOOXIDATION; PRIORITY JOURNAL; REVIEW; SHELF LIFE; SOLVENT EXTRACTION; STEREOCHEMISTRY; SUPERCRITICAL FLUID EXTRACTION; THIN LAYER CHROMATOGRAPHY; ULTRAVIOLET SPECTROSCOPY;

APIS;

EID: 79952770723     PISSN: 15734129     EISSN: None     Source Type: Journal    
DOI: 10.2174/157341211794708749     Document Type: Review

References (63)

1. Bari, S.; Kadam, B.; Jaiswal, Y.; Shirkhedkar, A. Impurity profile: significance in active pharmaceutical ingredient. Eurasian J. Anal. Chem., 2007, 2, 32-53.
2. Honrao M. Impurity Profile: A Review, Latest Reviews, 2005, 3.
3. Parimoo, P. A Text Book of Pharmaceutical Analysis, CBS publishers and distributors: New Delhi, 1998.
4. Kudal A. Impurity Profile of Active Pharmaceutical Ingredient: A Review, Latest Reviews, 2006, 4.
5. Impurities in New Drug Product Q3B(R); ICH Harmonised Tripartite Guidelines, International Conference on Harmonisation Draft Revised Guidance on Impurities in New Drug Products. 2000, pp. 44791-44797.
6. Impurities in New Drug Product Q3B(R); ICH Harmonised Tripartite Guidelines, International Conference on Harmonisation Draft Revised Guidance on Impurities in New Drug Products. 2000, pp. 45085.
7. Davis, J.M.; Gidding, J.C. Impurity profile: A review. J. Anal.Chem., 1983, 55, 418.
8. Alsante, K.M.; Hatajik, T.D.; Lohr, L.L.; Sharp T.R. Isolation and identification of process related impurities and degradation products from pharmaceutical drug candidates. Part 1. Am. Pharm. Rev., 2001, 4, 70.
9. Ahuja, S. Impurities Evaluation of Pharmaceuticals. Marcel Dekker: New York, 1998, pp. 42.
10. Beckett, A.H; Stanlake, J.B. Practical Pharmaceutical Chemistry. CBS Publishers and distributors: New Delhi, 2002.
11. Gorog, S. Identification and Determination of Impurities in Drugs. Elsevier Science Publishing Company: Amsterdam, 2000.
12. Jain, N. K.; Pharmaceutical Product Development. CBS Publications: New Delhi 2006, pp. 13.
13. Smith, A.; Pennefather, P.M.; Kaye, S.B.; Hart, C.A. Fluroquinolones Place in ocular therapy. Indian Drugs, 2001, 61(6), 747.
14. Roy, J.; Das, S.C. The effect of sunlight on ciprofloxacin eye drops. 2005, 14 (in press).
15. Condorelli, G.; Guidi D.G.; Giulfrido, S.; Sortino, S.; Chilleni, R.; Sciuto, S. Molecular mechanisms of photosensitization induced by drugs XII. Photochemistry and photosensitization of rufloxacin: An unusual photodegradation path for the antibacterials containing a fluoroquinolone-like chromophore. Photochemistry & Photobiology, 1999, 70(3), 280-286.
16. Bharucha, K. R.; Schrenk, H. M.; Clarke, E. S. Process for preparing Ampicillin. US Patent 4248780, February 3, 1981.
17. Roy, J. Pharmaceutical impurities a mini review. Biomedical and Life Sciences, 2002, 3.
18. Roy, J.; Mohammad, G.; Banu, A. Pharmaceutical analysis and stability of locally manufactured ampicillin trihydrate. Indian Drugs, 1993, 5, 211-218.
19. Impurities in New Drug Product Q3B(R2); ICH Harmonised Tripartite Guidelines. International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Current Step 4 Version, June 2, 2006.
20. Gimeno, P; Besacier, F; Bottex, M; Dujourdy, L; Chaudron, H. A study of impurities in intermediates and 3, 4 methylenedioxymeth-amphetamine (MDMA) samples produced via reductive animation routes. Forensic Sci. Int., 2005, 155, 14.
21. Cheng, J. Y. K.; Chan, M. F.; Chan, T. W.; Hung, M. Y. Impurity profiling of ecstasy tablets seized in Hong Kong by GC-MS. Forensic Sci. Int., 2006, 144, 21.
22. Krimpen, V.; Bennekom, W.P.; Bult, A. Penicillins and cephalosporins: physicochemical properties and analysis in pharmaceutical and biological matrices. Pharm. Weekbl. Sci., 1987, 9, 1-23.
23. Roy, J.; Islam, M.; Khan, A. H., Das, S. C.; Akhteruzzaman, M.; Deb, A. K.; Alam, A. H. Diclofenac sodium injection sterilized by autoclave and the occurrence of cyclic reaction producing a small amount of impurity. J. Pharm. Sci., 2001, 90, 541.
24. Buhler, V. Vademecum for Vitamin Formulation. Wiss, VerlGes., Germany, 1998, vol. 142, pp. 36.
25. Food and Drug Administration for Immediate Release Consumer Media, May 6, 1998, pp. 45.
26. Roy, J.; Mahmud, M.; Sobhan, A.; Aktheruzzaman, M.; Al-Faooque, M.; Ali, E. Marketed vitamin B-complex injectables: stability and mutual interaction. Drug Dev. Ind. Pharm., 1994, 20, 13, 2157.
27. Bart, C. J. Separation Techniques - Additives in Polymers: industrial analysis and applications. John Wiley and Sons. 2005, p. 212.
28. Still, W. C.; Kahn, M.; Mitra, A. Rapid chromatographic technique for preparative separations with moderate resolution. J. Org. Chem., 1978, 43(14), 2923-2925.
29. Bakshi, M.; Singh, S. Development of validated stability-indicating assay methods-critical review. 2002, 28, 1011-1040.
30. Lakshmi, K.S.; Sivasubramanian, L.; Pal, K. Stability indicating hptlc method for simultaneous determination ofTelmisartan and ramipril in tablets. Int. J. Pharm. Pharmaceut. Sci., 2010, 2(4), 975-1491.
31. Borole, T.C.; Mehendre, R.; Damle, M.C.; Bothara K.G. Development and validation of stability indicating HPTLC method for determination of Prasugrel. J. Chem. Pharm. Res., 2010, 2(4), 907-913.
32. Wankhede, S.B; Mahale, D.K; Chitlange, S.S. Stability-indicating HPTLC method for simultaneous determinationof Drotaverine and Aceclofenac in tablet formulation. Der. Pharma. Chemica, 2010, 2(5), 107-117.
33. Makhija, S.N; Vavia, P.R. Stability indicating HPTLC method for the simultaneous determination of pseudoephedrine and cetirizine in pharmaceutical formulations. J. Pharm. Biomed. Anal., 2001, 25, 663-667.
34. Subasranjan, A.; Suresh, P.; Srinivasulu, C.; Hemant, R. A validated stability-indicating gas chromatography method for determination of divalproex sodium impurities in pharmaceutical preparation. Drug Test. Anal., 2010, 2(4), 182-187.
35. Hunt-Fugate, A.K; Hennessey, C.K; Kazarian, C.M. Stability of fluconazole in injectable solutions. American J Hospital Pharm., 1993, 50(6), 1186-1187.
36. Watson, D. G. Pharmaceutical Analysis. Churchill Livingstone, 1999, 1, 75-76, 97-98, 145-146.
37. Raymond S. Chromatographic detectors design: Function and operation, Chromatographic science series, 1995, 73, 201-204.
38. Scott, R. P. W. HPLC: Principles and methods in Biotechnology, Wiley India, 2009, 71.
39. Shou, M.; Galinada, W.A.; Wei, Y.C.; Tang, Q.; Markovich, R.J; Rustum, A.M. Development and validation of stability-indicating HPLC method for simultaneous determination of salicylic acid, be-tamethasone dipropionate and their related compounds in Diprosalic Lotion. J. Pharm. Biomed. Anal., 2009, 50, 356-361.
40. Rao, R.N.; Nagaraju, V. Separation and determination of synthetic impurities of norfloxacin by reversed-phase high performance liquid chromatography. J. Pharm. Biomed. Anal., 2004, 34(5), 1049-1056.
41. Zaidi, Z.R.; Sena, F.J.; Basilio, C.P. Stability assay of allantoin in lotions and creams by high-pressure liquid chromatography. J. Pharm Sci., 1982, 71(9), 997-998.
42. Xiang, Y.; Liu Y.; Lee, M.L. Ultrahigh pressure liquid chromatography using elevated temperature. J. Chromatogra. A., 2006, 1104 (1-2), 198-202.
43. Still, W. C.; Kahn, M.; Mitra, A. Rapid chromatographic technique for preparative separation with moderate resolution. J. Org. Chem., 1978, 43(14), 2923-2925.
44. Campbell, M. A. Capillary Electrophoresis. Department of Biology, Davidson College, Davidson, NC 28036, 2002.
45. Hamdan, I.I.; Jaber, A.K.; Abushoffa, A.M. Development and validation of a stability indicating capillary electrophoresis method for the determination of metformin hydrochloride in tablets. J. Pharm. Biomed. Anal., 2010, 53(5), 1254-1257.
46. Sauber, C.; Ross, G. Impurity Profiling with Capillary Electropho-resis/Ion Trap Mass Spectrometry. Aplication Note, Agilent Technologies, USA, 2001.
47. Altria, K. D.; Rogan, M. M. Introduction to Quantitative Applications of Capillary Electrophoresis in Pharmaceutical Analysis. Beckman Coulter, 1994.
48. Terabe, S. Capillary separation: Micellar Electrokinetic Chromatography. Annu. Rev. Anal Chem., 2009, 2, 99-120.
49. Sangoi, M.S.; da Silva L.M.; D'Avila F.B.; Dalmora S.L. Determination of fluticasone propionate in nasal sprays by a validated stability-indicating MEKC method. J. Chromatogr. Sci., 2010, 48(8), 641-646.
50. Bretnall, A.E.; Hodgkinson, M.M.; Clarke, G.S. Micellar electrokinetic chromatography stability indicating assay and content uniformity determination for a cholesterol-lowering drug product. J. Pharm. Biomed. Anal., 1997, 15(8), 1071-1075.
51. Hobbie, R. K. Intermediate Physics for Medicine and Biology. Wiley: New York, 1988, 2.
52. Rohlf, J. W. Modern Physics from A to Z, Wiley: New York, 1994.
53. Becker, E. D. High Resolution NMR. Academic Press, 1969.
54. Pavia, D. L.; Lampman, G. M.; Kriz G. S. Introduction to Spectroscopy, Thomson Learning Inc. 2009, 3, pp. 540.
55. Silverstein, R. M.; Webster F. X.; Kiemle D. J. Spectrometric Identification of Organic Compounds, John Wiley & Sons, 1967, 7, 265.
56. Hanna, G. M.; Lau-cam, C.A. A Stability Indicating Proton NMR Spectroscopic Assay Method for Succinylcholine Chloride Injections. Anal. Lett., 1985, 17(18), 2183-2194.
57. Fiori, J.; Bragieri, M.; Zanotti, M.C.; Liverani, A.; Borzatta, V.; Mancini, F.; Cavrini, V.; Andrisano, V. LC-TMS for the identification of impurities in d-allethrine samples. J. Chromatogr, 2005, 1099, 149.
58. Greenlief, UV Vis Absorption Spectroscopy. CH 4200, Fall, 2004.
59. Salo, K.J.; Hannele, S. Two stability-indicating UV spectropho-tometric methods for the analysis of hydrolyzed tinidazole. J. Pharm. Biomed. Anal., 2003, 31(3), 523-536.
60. Highfield, J. G.; Moffat, J. B. Characterization of 12-tungstophosphoric acid and related salts using photoacoustic spectroscopy in the infrared region: I. Thermal stability and interactions with ammonia. J. Catal., 1984, 88(1), 177-187.
61. th ed. Thomson Brooks/Cole. 2007, 349-351.
62. Berridge, J. C. Impurities in drug substances and drug products: new approaches to quantification and qualification. J. Pharm. Biomed. Anal., 1995, 14, 7-12.
63. Reddy, Y. R.; Nandan, S. R.; Bharathi, D. V.; Nagaraju, B.; Reddy, S. S.; Ravindranath, L.K.; Rao, V. S. LC and LC-MS/MS study of force decomposition behaviour of anastrozole and establishment of validated stability-indicating analytical method for impurities estimation in low dose anastrozole tablets. J. Pharm. Biomed. Anal., 2009, 50, 397-404.