A Review on Analytical Method Validation

Authors

  • Ms. Nilam Bavdhane  Bachelor of Pharmacy, PDEA's Shankarrao Ursal College of Pharmaceutical Science's and Research Centre, Kharadi, Pune-14, Maharashtra, India.
  • Dr. Vijaya Barge  Vice principal, pharmaceutical quality assurance department, PDEA's Shankarrao Ursal College of Pharmaceutical Science's and Research Centre, Kharadi, Pune-14, Maharashtra, India

DOI:

https://doi.org/10.32628/IJSRST52411162

Keywords:

Analytical Method Development, Validation Parameters, Acceptance Criteria

Abstract

The process of finding new drugs, releasing them onto the market, and developing them further to get a marketing approval all depend critically on the development of sound analytical method(s). Aims to achieve; this study reviews the development, optimization, and validation of the drug's technique. Product from the formulation's early stages of development to the product's commercial batch. Approach development for the interested party in process tests, the sample, or the final product manufacturing of the therapeutic product and to offer useful methods for figuring out selectivity, specificity, detection limit, quantitation limit, linearity, range, accuracy, precision, stability of the recovery solution, liquid chromatographic techniques' resilience and robustness to enable routine, in-process, and analysis of stability.

References

  1. Thompson M, Ellison SLR and Wood R. Harmonised Guidelines for single Laboratory Validation of Method of Analysis. Pure Appl Chem. 2008; 74:835-55.
  2. Wood R. How to Validate Analytical Methods. Trends Analyt Chem. 2005;54:149-58
  3. McDowall RD. The Role of Laboratory information Management systems LIMS in Analytical Method Validation. Anal Chim Acta. 2077; 54:149-58.
  4. Puluido A, Ruusanches I, Boquc R and Rius FX. Uncertainty of results ID routine Qualitative Analysis in Analytical Chemistry. J Pharm Biomed Anal. 2005;22:647-54
  5. Boggula, N., Kasturi, J., Reddy, P., & Bakshi, V. (2019). Non-steroidal antiinflammatory drugs: an overview. Journal of Drug Delivery & Therapeutics, 9(1-s),442-448
  6. Behera, S. (2012). UV-Visible Spectrophotometric Method Development and Validation of Assay of Paracetamol Tablet Formulation. Journal of Analytical And Bioanalytical Techniques
  7. Lavanya G, Sunil M, Eswarudu MM, Eswaraiah MC, Harisudha K, Spandana BN. Analytical method validation: an updated review. International Journal of Pharmaceutical Sciences and Research. 2013 Apr 1;4(4):1280
  8. Verma P, Madhav NS, KR Gupta V. A review article on pharmaceutical validation and process controls. Pharma Innovation 2012; 1:51-60.
  9. Borisagar, S. L., Patel, H. U., Patel, A. N., & Patel, C. N. (2017). A Validated HPLC Method for Estimation of Lornoxicam and Paracetamol in their Combined Tablet Dosage Form. Internation Journal of Pharmacetical Sciences and Research, 1683-1686.
  10. Nash R. A. and Wachter A. H Pharmaceutical Process Validation an International Third Edition. Revised and Expanded, Marcel Dekkar, Inc., New York 2003; 129, P. 760-792
  11. Bhardwaj SK, Dwivedi K, Agarwal DD. A review: HPLC method development and validation. Int J Anal Bioanal Chem 2015; 5:76-1.
  12. Dash, D. K., & Vadher, M. (2014). Analytical Method Development and Validation for Simultaneous Determination of Zaltoprofen and Paracetamol in their Combined Solid Dosage
  13. Gaikwad, R., Chadhari, F., Kande, T., & Barge, V. (2017). Development and Validation of Analytical Mehtod for Simultaneous Estimation of Paracetamol and Ibuprofen Using UV Visible Spectroscopy. Human Journal Research Article.
  14. Tangri Pranshu, Rawat Prakash Singh, Jakhmola Vikash: Validation: A Critical Parameter for Quality Control of Pharmaceuticals. Journal of Drug Delivery & Therapeutics 2012; 2(3): 34-40
  15. Ravichandran V, Shalini S, Sundram KM, Rajak H (2010) Validation of analytical methods strategies & importance. Int J Pharmacy and Pharm Sci 2: 18-22
  16. ICH Harmonized tripartite guidelines, Validation of Analytical Procedures’: Text and Methodology, Q2 (R1), current step 4 version; 27 Oct 1994. [2]
  17. Naga G. R., Vignesh K., Analytical Method Validation: An Updated Review, IJAPBC- Vol.1 (1), Jan- Mar, 2012.
  18. Ravichandran.V, Shalini s, and Harish Rajak, Validation of analytical Methods-Strategies and Importance. Vol.2, 3 May 2010.
  19. Shah.K, Kumar.S, Upmanyu.N and Mishra.P, Review Article on, “Evaluation of an Analytical Method” IJPCR, Vol.1 issue 1, 2012
  20. Moharana AK, Banerjee M, Sahoo CK, Sahoo NK (2011) Development and validation of RP-HPLC method for Mesalamine. Asian J of Pharmaceutical and Clinical Reserch4:71-73
  21. Hokanson GC (1994) a life cycle approach to the validation of analytical methods during pharmaceutical product development part I: The initial validation process. Pharmaceutical Technology: 118-130.
  22. Sahoo NK, Sahu M, Veerachamy A, Lalitha BV, Moharana AK, et al. (2015) Quantification and validation of simvastatin and ezetimibe in bulk drugs and combined dosage form by reverse phase liquid chromatographic method (RPLC). Pharmaceutical Methods 6: 115-119
  23. Sahoo NK, Sahu M, Praneeth P, Manjeera PSK, Lavanya K (2013) Degradation motitoring method development and validation of spectrophotometric estimation of atrovastatin calcium in bulk and tablet formulation. J Pharm. Biomed Sci 33: 1551-1557.
  24. Patel NK, Subhaiah G, Shah H, Kundlik M, Shrivastav SP (2008) Rapid LC-ESI-MS-MS method for the simultaneous determination of clopidogrel and its carboxylic acid metabolite in human plasma. J Chromatogr Sci 46: 867-875
  25. Sahoo NK, Sahu M, Alagarsamy V, Srividya B, Sahoo CK (2015) Current status of two-dimensional gel validation of assay indicating method development of imatinib in bulk and its capsule dosage form by liquid chromatography. Ann Chromatogr Sep Tech 1: 1010
  26. Renger B, Jehle H, Fischer M, Funk W (1995) Validation of analytical procedures in pharmaceutical analytical chemistry: HPTLC assay of theophylline in an effervescent tablet. J Planar Chrom 8: 269-278.
  27. Vander HY, Nijhuis A, Verbeke JS, Vandegtnste BG, Massart DL (2009) Guidance for robustness/ruggedness test in method validation. J Pharm Biomed Anal 24: 723-53.
  28. Sahoo NK, Sahu M, Rao PS, Indira JN, Rani SN, et al. (2014) Validation of assay for bulk clopidogrel and for some tablet forms by reverse phase high performance liquid chromatography. J of Taibah University for Science 8: 331-336.
  29. Panda SS (2010) Ion pairing RP-HPLC method for simultaneous determination of aspirin and clopidogrel bisulphate in tablet and capsule dosage form. Int J PharmTech Res 2: 269-273
  30. David G Watson, High Performance Liquid Chromatography, Pharmaceutical Analysis-A Text Book for Pharmacy Students and Pharmaceutical Chemists, 1st Ed, 1999, 237-276.
  31. George Lunn, Methoxychlor, HPLC Methods for Recently Approved Pharmaceuticals, 1st Ed, 2005, 387.
  32. Guidance for Industry, Q2 (R1) Validation of
  33. Analytical Procedures: Methodology, U.S.Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), Centre for Biologics Evaluation and Research (CBER), International Conference on Harmonization, Geneva, November 2005.
  34. Indian Pharmacopoeia, Vol. I , II & III, Government of India, Ministry of Health and family Welfare, Controller of Publications, Delhi, 2007, Vol-II, 96-98.
  35. Indian Pharmacopoeia, Vol. I , II & III, Government of India, Ministry of Health and family Welfare, Controller of Publications, Delhi, 2007, Vol-II, 129-131.
  36. International Conference on Harmonization (ICH), Validation of analytical procedure: Text and methodology, Harmonized tripartite guideline, Q2 (R1), Geneva, 2005.
  37. Jay Br, Kelvin J, Pierre B, Understanding and Implementing Efficient Analytical Methods
  38. Development and Validation, 2003, Available from: http://www.pharmtech.comLloyd R, Snyder, Joseph J Kirkland, Joseph L Glajch, Practical HPLC Method Development, 2nd Ed., 1997, 179-184.
  39. Mendham J, Denny R C, Barns J D, Vogel’s Text Book of Quantitative Chemical analysis, 6th Ed, 2001, 289, 297-305.
  40. Quality assurance of pharmaceuticals: A compendium of guidelines and related materials, Volume 2, 2nd updated edition, Good manufacturing practices and inspection, World Health Organization, 129-131.
  41. Ravisankar S, HPLC, Textbook of Pharmaceutical Analysis, 3rd Ed, 2006, 18(1)-18(15)
  42. Skoog DA, Holler FJ, Crouch SR, Principles of Instrumental Analysis, 6th Ed, Baba barkahanath printers, Haryana, 2007, 816-855.
  43. United States Pharmacopoeia 24, national formulary 19, section <1225> “Validation of compendial methods”, US Pharmacopoeial convention, Rockville, 2000.
  44. United States Pharmacopoeia 27, section <621> “system suitability”, US Pharmacopoeial convention, Rockville, 2004
  45. US FDA, Technical Review Guide: Validation of chromatographic Methods, 1993,726.
  46. W John Lough, Encyclopedia of Analytical Chemistry: Application, Theory and Instrumentation by R A Meyers, 1st Ed, 2000, 12173-12180.
  47. Willard H, Merritt L, Dean J A, Settle F A, Instrumental methods of analysis, 7th Ed, CBS Publishers & Distributor, New Delhi, 1986, 580-655.
  48. G. David Watson, Pharmaceutical Analysis (3rd Ed., Churchill Livingstone, London: Harcourt Publishers Limited, Essex CM 20 2JE, 2012A.
  49. H. Beckett, and J.B. Stenlake, Practical Pharmaceutical Chemistry (4th Ed., Vol. I & II. CBS Publishers and Distributors, New Delhi: 2007).
  50. T. Higuchi, and Brochman-Hansen, Pharmaceutical Analysis, (3rd edition, CBS Publishers and Distributors pvt. Ltd., New Delhi: 1997.
  51. G. Oliver, R. Gerrit, and VZ. Maxmilian, Leading Pharmaceutical Innovation, „Trends and drivers for Growth in the pharmaceutical industry, (2nd Ed., Springer, 2008)12-15.
  52. Br. Jay, J. Kelvin, and B. Pierre, Understanding and Implementing Efficient Analytical Methods Development and Validation, 2003.
  53. R.M. Christopher, and W.R. Thomas, Quality Systems approach to Pharmaceutical cGMP Development and validation of Analytical Methods, (1st Ed., 2005) 147-152.
  54. R. Lloyd Snyder, J. Joseph Kirkland and L. Joseph Glajah, Practical HPLC method development (2nd Ed., 1997) 179-184.
  55. B.K. Sharma, Instrumental method of chemical analysis (29th Ed., Meerut, Chromatography, HPLC, Goel Publishing House, 2013) 286-385.
  56. H.H. Willard, L.L. Merrit, J.A. Jr. Dean, and F.A. Jr. Settle, Instrumental Methods of Analysis (CBS Publishers, New Delhi: 1986).
  57. R.A. Day, and A.L, Underwood, Quantitative Analyses, (5th Ed., Prentice Hall, New Delhi: 1986).
  58. Macek and Karel, Pharmaceutical Applications of Thin Layer and Paper Chromatography, 62(6) 1972,1032.
  59. G. Ramana Rao, S.S.N. Murthy, and P. Khadgapathi, Gas Chromatography to Pharmaceutical Analysis, Eastern Pharmacist, 30(353), 1987, 35.
  60. G. Ramana Rao, S.S.N. Murthy, and P. Khadgapathi, High Performance Liquid Chromatography and its Role in Pharmaceutical Analysis, Eastern Pharmacist, 29(346), 1986, 53.
  61. C.S.P. Sastry, T.N.V. Prasad, and E.V. Rao, Recent applications of High Performance Liquid chromatography in Pharmaceutical analysis, Indian J. Pharm. Education, 21 (37),1987.
  62. Ravisankar P, Gowthami S, and Devala Rao G, A review on analytical method development, Indian journal of research in pharmacy and biotechnology, 2(3), 2014, 1183-1195.
  63. Ravisankar P, Rajyalakshmi G, Devadasu Ch, and Devala Rao G, Instant tips for right and effective approach to solve HPLC trouble shooting, Journal of chemical and pharmaceutical sciences. 7(3), 2014, 259-274.
  64. Jay Breaux, Kevin Jones, and Pierre Boulas, Development services analytical method development and validation „Pharmaceutical technology, 27(1), 2003, 6-13.
  65. E. Michael Swartz, and Iras Krull, Analytical method development and validation, CRC press, Marcel dekker, Inc., Madison Avenue, New York: 1997.
  66. K. Yuri, and LB. Rosario, HPLC for pharmaceutical scientists, (John Wiley and Sons, Inc., Hoboken, New Jersey, 2007) 92-98.
  67. G. P. Carr, and J. C. Wahlichs. „A practical approach to method validation in pharmaceutical analysis‟, J. Pharm, Biomed. Anal, 8, 1990, 613-618.
  68. United States Pharmacopoeia, 24, National Formulary 19, section „Validation of compendial methods‟. US Pharmacopoeial convention, Rockville, Validation of analytical procedures text and methodology Q2 (R1), November, 2000: 2005
  69. International conference on harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use, Validation of analytical procedures: Text methodology, (Q2 (R1) Geneva, 2005) 6-13.
  70. Draft guidance analytical procedures and method validation, US food and drug administration, Centre for drugs and biologics, Department of Health and Human Services. http://www.fda.gov/cder/guidance/2396 dft.htm#111, 2000.
  71. Orr J.D, Krull I.S and Swartz M.E, Validation of impurity methods Part II, (LC North Am; 21, 2003) 1146-1152.
  72. ICH Q2 (R1), Validation of analytical procedures (definitions and terminology); 2005; pp. 9-10.
  73. D.L. Massart, B.G.M. Vandeginste, S.N. Deming, Y. Michotte and L. Kaufman, Chemometrics: A Text Book, Elsevier, And Amsterdam: 1988.
  74. M.M. Kiser and J.W. Dolan, Selecting the best curve fit LC-GC (Europe: 2004)138-143.
  75. R.E. Moore, Interval analysis (Englewood Cliffs, NJ: Prentice-Hall, 1966).
  76. Development and validation of HPLC method a review. International Re-search Jour- nal of Pharmaceutical and Ap-plied Sciences. 2012; 2(4):22-23.
  77. .N. Toomula, A. Kumar, S. D. Kumar, V.S. Bheemidi, Develop- ment and Validation of Analytical Methods for Pharmaceuticals, J. Anal. Bioanal. Techniques. 2011; 2(5): 1-4. 
  78. B. Nigovic, A. Moran, M. Sertic, Chromato-graphy-The Most Versatile Method of Chemi-cal Analysis, Intech. 385-425 (2012). 
  79. K. Kardani, N. Gurav, B. Solanki, P. Patel, B. Patel, RP-HPLC Method Development and Validation of Gallic acid in Polyherbal Tablet Formulation, Journal of Applied Pharmaceuti-cal Science. 2013; 3(5): 37-42. 
  80. International Conference on Harmonization, Draft Guidance on specifications, Test proce-dures and acceptance criteria for new drug substances and products, Chemical Sub-stances. Fed. Regist. 2000; 3(5): 83041-63.
  81. Putheti RR, Okigbo RN, Patil SC, Advanapu MS, Leburu R. Method development and vali-dations, Characterization of critical elements in the development of pharma- ceuticals. Int J Health Res. 2008; 1:11-20.
  82. Wood R. How to Validate Analytical Methods. Trends Analyt Chem. 2005; 54: 149-58.
  83. Vessman J. Selectivity or specifi- city? Valida-tion of analytical methods from the perspec-tive of an analytical chemist in the pharma-ceutical industry. J Pharm Biomed Analyt, 1996; 14:867-9. 
  84. Hearn Perkin Elmer RA. www.standardbase.com., A Guide to Valida-tion in HPLC Based on the Work of G. M. Hol-land.
  85. Lindner W, Wainer IW, Require- ments for initial assay validation and publication in J Chromatltography B. J Chromatogr. 2006; 707: 1.2.
  86. Validation of Compendial Proce- dures, Unit-ed State Pharmacopeia, USP 36 NF, 27 (2) (2010). 
  87. Validation of Analytical Procedures: Text and Methodology, International Conferences on Harmonization, Draft Revised (2005), Q2 (R1). 
  88. Boulanger B, Chiap P, Dewe W, Crommen J, Hubert P. An analysis of the SFSTP guide on validation of chromatographic Bioanalytical meth- odds: progress and limitations. J Pharm Biomed Anal. 2003; 32:753-65.

International Journal of Scientific Research in Science and Technology

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Published

2024-02-29

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Volume 11, Issue 1, January-February-2024

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Research Articles

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[1]
Ms. Nilam Bavdhane, Dr. Vijaya Barge "A Review on Analytical Method Validation" International Journal of Scientific Research in Science and Technology(IJSRST), Online ISSN : 2395-602X, Print ISSN : 2395-6011,Volume 11, Issue 1, pp.432-444, January-February-2024. Available at doi : https://doi.org/10.32628/IJSRST52411162