A review on analytical method validation and its regulatory perspectives
Abstract
Analytical methods plays vital role in the process of identification, separation and then quantification of chemical components in natural materials or synthetic materials based on their chemistry. The main purpose of the analytical method development and validation is to prove that proposed analytical method is accurate, specific, precise and robust in the pharmaceutical industry for analysis of a drug moiety. Analytical method development gives important information in the pharmaceutical industry, on the potency of a drug, the drug’s bioavailability, the drug’s stability and also its effects. The analytical method validation is essential for analytical method development and tested for specificity, linearity, accuracy, precision, range, detection limit, quantitation limit and robustness. In summary, analytical method development and validation confirms that an accurate, precise and reliable potency measurement of a pharmaceutical preparation can be performed.
Keywords: HPLC, HPTLC, UPLC, GC, MS, SOP
DOI
https://doi.org/10.22270/jddt.v9i2.2403References
David Watson G, Pharmaceutical Analysis (3rd Ed., Churchill Livingstone, London: Harcourt Publishers Limited, Essex CM 20 2JE, 2012).
Beckett AH, and Stenlake JB, Practical Pharmaceutical Chemistry (4th Ed., Vol. I & II. CBS Publishers and Distributors, New Delhi: 2007).
Higuchi T, and Brochman-Hansen, Pharmaceutical Analysis, (3rd edition, CBS Publishers and Distributors pvt. Ltd., New Delhi:1997).
Oliver G, Gerrit R, and Maxmilian VZ, Leading Pharmaceutical Innovation, „Trends and drivers for Growth in the pharmaceutical industry, (2nd Ed., Springer, 2008)12-15.
Br. Jay, J. Kelvin, and B. Pierre, Understanding and Implementing Efficient Analytical Methods Development and Validation, 2003.
R.M. Christopher, and W.R. Thomas, Quality Systems approach to Pharmaceutical cGMP Development and validation of Analytical Methods, (1st Ed., 2005) 147-152.
R. Lloyd Snyder, J. Joseph Kirkland and L. Joseph Glajah, Practical HPLC method development (2nd Ed., 1997) 179-184.
Sharma BK, Instrumental method of chemical analysis (29th Ed., Meerut, Chromatography, HPLC, Goel Publishing House, 2013) 286-385.
Joachim E, John HM. Miller (Eds.), Method validation in pharmaceutical analysis: A guide to best practice (Wiley-VCH verlag Gmbh & co., Weinheim: 2005).
Siddiqui MR, Alothman ZA, Rahman N, Analytical techniques in pharmaceutical analysis: A review,Arabian Journal of chemistry, 2017; 10:S1409-S1421.
Yoshiko A, Basic Education in Analytical Chemistry (Analytical Sciences, 17 Supplement: 2014).
Willard HH, Merrit LL, Jr. Dean JA, and Jr. Settle FA, Instrumental Methods of Analysis (CBS Publishers, New Delhi: 1986).
Day RA, and Underwood AL, Quantitative Analyses, (5th Ed., Prentice Hall, New Delhi: 1986).
Macek and Karel, Pharmaceutical Applications of Thin Layer and Paper Chromatography, 1972; 62(6):1032.
Ramana Rao G, Murthy SSN, and Khadgapathi P, Gas Chromatography to Pharmaceutical Analysis, Eastern Pharmacist, 1987; 30(353):35.
Ramana Rao G, Murthy SSN, and Khadgapathi P, High Performance Liquid Chromatography and its Role in Pharmaceutical Analysis, Eastern Pharmacist, 1986; 29(346):53.
Sastry C.S.P., Prasad T.N.V., and Rao E.V., Recent applications of High Performance Liquid chromatography in Pharmaceutical analysis, Indian J. Pharm. Education, 21 (37),1987.
Ravisankar P, Gowthami S, and Devala Rao G, A review on analytical method development, Indian journal of research in pharmacy and biotechnology, 2014; 2(3):1183-1195.
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. 2014; 7(3):259-274.
Jay Breaux, Kevin Jones, and Pierre Boulas, “Development services analytical method development and validation” Pharmaceutical technology, 2003; 27(1):6-13.
E. Michael Swartz, and Iras Krull, Analytical method development and validation, CRC press, Marcel dekker, Inc., Madison Avenue, New York: 1997.
Carr GP and Wahlichs JC. “A practical approach to method validation in pharmaceutical analysis”, J. Pharm, Biomed. Anal, 1990; 8:613-618.
United States Pharmacopoeia,24, National Formulary 19, section <1225> „Validation of compendial methods‟. US Pharmacopoeial convention, Rockville, Validation of analytical procedures text and methodology Q2 (R1), November, 2000: 2005.
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.
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.
Orr J.D, Krull I.S and Swartz M.E, Validation of impurity methods Part II, (LC North Am; 21, 2003) 1146-1152.
Published
Abstract Display: 2923 
PDF Downloads: 1443 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.