A review on analytical method validation and its regulatory perspectives

  • Basant Lal Research Scholar, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan
  • Devesh Kapoor Dr. Dayaram Patel Pharmacy College, Sardar baug, Station Road, Bardoli, Dist – Surat, Gujarat, India, Pin-394601
  • Manish Jaimini Dean, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

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

Downloads

Download data is not yet available.

Author Biographies

Basant Lal, Research Scholar, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

Research Scholar, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

Devesh Kapoor, Dr. Dayaram Patel Pharmacy College, Sardar baug, Station Road, Bardoli, Dist – Surat, Gujarat, India, Pin-394601

Dr. Dayaram Patel Pharmacy College, Sardar baug, Station Road, Bardoli, Dist – Surat, Gujarat, India, Pin-394601

Manish Jaimini, Dean, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

Dean, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

References

[1] David Watson G, Pharmaceutical Analysis (3rd Ed., Churchill Livingstone, London: Harcourt Publishers Limited, Essex CM 20 2JE, 2012).
[2] Beckett AH, and Stenlake JB, Practical Pharmaceutical Chemistry (4th Ed., Vol. I & II. CBS Publishers and Distributors, New Delhi: 2007).
[3] Higuchi T, and Brochman-Hansen, Pharmaceutical Analysis, (3rd edition, CBS Publishers and Distributors pvt. Ltd., New Delhi:1997).
[4] 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.
[5] Br. Jay, J. Kelvin, and B. Pierre, Understanding and Implementing Efficient Analytical Methods Development and Validation, 2003.
[6] R.M. Christopher, and W.R. Thomas, Quality Systems approach to Pharmaceutical cGMP Development and validation of Analytical Methods, (1st Ed., 2005) 147-152.
[7] R. Lloyd Snyder, J. Joseph Kirkland and L. Joseph Glajah, Practical HPLC method development (2nd Ed., 1997) 179-184.
[8] Sharma BK, Instrumental method of chemical analysis (29th Ed., Meerut, Chromatography, HPLC, Goel Publishing House, 2013) 286-385.
[9] Joachim E, John HM. Miller (Eds.), Method validation in pharmaceutical analysis: A guide to best practice (Wiley-VCH verlag Gmbh & co., Weinheim: 2005).
[10] Siddiqui MR, Alothman ZA, Rahman N, Analytical techniques in pharmaceutical analysis: A review,Arabian Journal of chemistry, 2017; 10:S1409-S1421.
[11] Yoshiko A, Basic Education in Analytical Chemistry (Analytical Sciences, 17 Supplement: 2014).
[12] Willard HH, Merrit LL, Jr. Dean JA, and Jr. Settle FA, Instrumental Methods of Analysis (CBS Publishers, New Delhi: 1986).
[13] Day RA, and Underwood AL, Quantitative Analyses, (5th Ed., Prentice Hall, New Delhi: 1986).
[14] Macek and Karel, Pharmaceutical Applications of Thin Layer and Paper Chromatography, 1972; 62(6):1032.
[15] Ramana Rao G, Murthy SSN, and Khadgapathi P, Gas Chromatography to Pharmaceutical Analysis, Eastern Pharmacist, 1987; 30(353):35.
[16] Ramana Rao G, Murthy SSN, and Khadgapathi P, High Performance Liquid Chromatography and its Role in Pharmaceutical Analysis, Eastern Pharmacist, 1986; 29(346):53.
[17] 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.
[18] 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.
[19] 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.
[20] Jay Breaux, Kevin Jones, and Pierre Boulas, “Development services analytical method development and validation” Pharmaceutical technology, 2003; 27(1):6-13.
[21] E. Michael Swartz, and Iras Krull, Analytical method development and validation, CRC press, Marcel dekker, Inc., Madison Avenue, New York: 1997.
[22] Carr GP and Wahlichs JC. “A practical approach to method validation in pharmaceutical analysis”, J. Pharm, Biomed. Anal, 1990; 8:613-618.
[23] 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.
[24] 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.
[25] 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.
[26] Orr J.D, Krull I.S and Swartz M.E, Validation of impurity methods Part II, (LC North Am; 21, 2003) 1146-1152.
Statistics
193 Views | 196 Downloads
How to Cite
Lal, B., Kapoor, D., & Jaimini, M. (2019). A review on analytical method validation and its regulatory perspectives. Journal of Drug Delivery and Therapeutics, 9(2), 501-506. https://doi.org/10.22270/jddt.v9i2.2403