Volume : 08, Issue : 05, May – 2021
Title:
25.A REVIEW ON BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION
Authors :
V. Supriya *, Md. Shakirunisa, O. Krupa Santhi, T. Sandhya Rani, Ch. Anupama Swathi, Dr. K. Padmalatha
Abstract :
In bioanalytical methods are widely used to quantitative drugs and their metabolites in plasma matrices and the methods should be applied to studies in areas of human clinical and nonhuman study. Bioanalytical method employed for the quantitative estimation of drugs and their metabolites in biological media and plays an important role in estimation and interpretation bioequivalence, pharmacokinetic, toxicokinetic, studies. The major bioanalytical role is method development and sample analysis liquid-chromatography coupled with double mass spectroscopy can be used for the bioanalysis of drugs in body. Each of the instruments has its own merits and demerits. Chromatographic methods are HPLC and gas chromatography have been mainly used for the bioanalysis of small/large molecules, with LC/MS. Linearity, accuracy, precision, selectivity, sensitivity, reproducibility, and stability are some of the regularly used parameters. In this review article, we are proposed to add some points regarding bioanalytical method development and validation parameter, beneficial to quality assurance to determine the drug, concentration and its metabolite.
Keywords: Method development, clinical and nonclinical study, analyte, validation of bioanalysis techniques, validation parameter.
Cite This Article:
Please cite this article in press V. Supriya et al., A Review On Bioanalytical Method Development And Validation.., Indo Am. J. P. Sci, 2021; 08(05).
Number of Downloads : 10
References:
1. Arokand, gangadharappa H.V. An approach to bioanalytical method development and validation: A review. Int J pharm Sci Res.2016; 7(6):2291-2301.
2. Buick A.R, Doig M.V, Jeal S.C, Land G.S, McDowall R.D. Method validation in the bioanalytical laboratory. J Pharm Biomed Anal 1990;8(12):629-637.
3. Causon R. validation of chromatographic methods in biomedical analysis. Viewpoint and discussion. J Chromatogr B Biomed Sci Appl 1997;689(1):175-180.
4. Chiu M.L, Lawi W, Snyder S.T, Wong P.K, Liao J.C, Gau V. Matrix effects: A challenge toward automation of molecular analysis. J Assoc Lab Autom 2010; 15:233-242.
5. Food and drug administration. Guidance for industry: Bioanalytical method Validation. Rockville, MD: U.S Department of health and Human services. Food and Drug administration; 2001; 13: 385394.
6. Hartmann C, Meyers-Verbeke J, MassArt D.L, McDowall R.D. Validation of bioanalytical chromatographic methods. J Pharm Biomed Anal 1998; 17(2): 193-218.
7. Heydon V.Y, Nijhuis A, Smeyers-Verbeke J, Vandeginste B.G, MassArt D.L. Guidance for robustness/ruggedness tests in method validation. J Pharm Biomed Anal 2001; (5-6):723-753.
8. International conference on harmonization (ICH), Q2A: Text on Validation of Analytical procedures, March 1995.
9. International conference on harmonization (ICH), Q2B: Validation of analytical procedures: Methodology, May 1997.
10. Jhang J.S, Chang C.C, Fink D. J, Kroll M.H. Evaluation of linearity in the clinical laboratory. Arch Pathol Lab Med 2004; 128(1):44-48.
11. Kallner A. Quality specifications based on the uncertainity of measurement. Scand J Clin Lab Invest 1999; 59(7):513-516.
12. Kirthi A, Shanmugam R, Prathyusha M.S and Basha O. J. A review on bioanalytical method development and validation by RP-HPCL. J Global trends Pharm Sci. 2014; 5(4): 2265-2271.
13. Lang J.R, Bolton S. A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry-1. Experimental considerations, J Pharm Biomed Anal 1991; 9(5): 357361.
14. Mark H. Application of improved procedure for testing linearity of analytical method to pharmaceutical analysis. J Pharm Biomed Anal 2003; 33(1):7-20.
15. McDowall R.D. The role of laboratory information management systems LIMS in analytical method validation. Anal Chime Acta 2007; 54:149-158.
16. Pulido A, Revanches I, Bosque R, Reus FX. Uncertainity of results in routine qualitative analysis in analytical chemistry. J Pharm Biomed Anal 2005;22: 647-654.
17. Rao K.R, Kumar K.S. Bioanalytical method validation- A quality assurance auditor view point. J Pharm Sci Res 2009;1(3):1-10.
18. Reddy K.V, Yachawad A. Overview of recent extraction techniques in bioanalysis. Int Res J Pharm. 2016; 7(2):15-20.
19. Reid E, Wilson ID. Methodological survey in biochemistry and analysis. Analysis for Drug and Metabolites, Including Anti-Infective Agents. Vol.20.Cambridge. England: Royal Soc Chem. 1990;1-57.
20. Shah V.P. The history of bioanalytical method validation and regulation: Evolution of a guidance document on bioanalytical method validation. AAPS J 2007; 9(1); 43-47.
21. Sharma G.N, Singhal M. M, Sharma K. K, Sandhya J. Trouble shooting during bioanalytical estimation of drug and metabolites using LC-MS/MS: A review. J Adv Pharm Techno Res 2018; 1(1).
22. Sona wane et al. Bioanalytical method validation and its pharmaceutical application. A Review pharmaceutical Acta. 2014;5(3). 288.
23. Surendra B, Destefano A. Key elements of bioanalytical method validation for small molecules. AAPS J 2007;9(1): 109-114.
24. Thompson M, Ellison SL, Wood R. Harmonized guidelines for single laboratory validation of method of analysis. Pure Appl chem 2008; 74(5): 835-855.
25. Tijare L.K, Rangari N.T and Mahajan V.N. A review on bioanalytical method development and validation. Asian J Pharm Clin Res.2016; 9(3):6-10.
26. Tijare L.K, Rangari N.T and Mahajan V.N. A review on bioanalytical method development and validation. Asian J Pharm Clin Res. 2016; 9(3):6-10.
27. Tiwari G, Tiwari R. Bioanalytical method validation: An updated review. Pharm Methods 2010; 1(1): 25-38.
28. U.S Centre for drug Evaluation and Research, Reviewer Guidance: Validation of chromathographic methods, November 1994.
29. Wells D. A. High throughput bioanalytical sample preparation: Methods and automation strategies. Prog pharm Biomed Anal. Amsterdam, London: Elsevier;2003; 30:610.
30. Wood r. How to validate analytical methods. Trends Analyst Chem 2005; 18: 624-632.