[Home ] [Archive]   [ فارسی ]  
:: Main :: About :: Current Issue :: Archive :: Search :: Submit :: Contact ::
Main Menu
Home::
Journal Information::
About the Journal
Editorial Board
Aims& Scopes
Journal News
Articles archive::
Current Issue
All Issues
Browse by Authors
Browse by Keywords
For Authors::
Call for Papers
Submission Instruction
Submission Form
For Reviewers::
Reviewers Section
Registration::
Registration Information
Registration Form
Contact us::
Contact Information
Contact us
Site Facilities::
Site map
Search contents
FAQ
Top 10 contents
Inform to friends
Webmail::
::
Search in website

Advanced Search
..
Receive site information
Enter your Email in the following box to receive the site news and information.
..
:: Volume 35, Issue 3 (Fall 2025) ::
MEDICAL SCIENCES 2025, 35(3): 275-285 Back to browse issues page
A review on high-performance liquid chromatography method design and development
Seyed Mohammad Alavi1 , Amir Beheshti Maal1 , Hoda Jahandar2
1- PhD student in Pharmacy, Faculty of Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran
2- Assistant Professor, Department of Medicinal Plants, Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Tehran Medical Sciences Branch, Islamic Azad University, Tehran, Iran , ho_jahandar@yahoo.com
Abstract:   (209 Views)
High performance liquid chromatography is a suitable method for the separation, identification and measurement of components in samples. In the pharmaceutical industry, this method is very important for the analysis of impurities and active pharmaceutical ingredients in the quality control of pharmaceutical products, stability studies and evaluation of new formulations. With the daily emergence of new drugs and pharmaceutical formulations, the need to design and develop analysis methods with high-performance liquid chromatography has also increased. The purpose of this review article is to investigate how to develop an analysis method using high-performance liquid chromatography and related influencing factors. The databases including PubMed, Google Scholar, and Google were utilized with the keywords HPLC, HPLC Method Development, HPLC Method optimization, HPLC Method troubleshooting and HPLC Method validation to find articles related to method design and development. Additionally, the book “Principles of Instrumental Analysis” was used as a guide. Factors such as column type, mobile phase composition, HPLC Separation modes, detector, modes of elution and examination of the physicochemical properties of the drug are important parameters in the design and development of a HPLC method.
 
Keywords: High-performance liquid chromatography, Method design and development, Drug analysis
Full-Text [PDF 763 kb]   (109 Downloads)    
Semi-pilot: Review | Subject: Pharmacology
Received: 2024/05/27 | Accepted: 2024/08/6 | Published: 2025/09/1
References
1. Sabir AM, Moloy M, Bhasin PS. HPLC method development and validation: A review. Int Res J Pharmacy 2013;4:39-46. [DOI:10.7897/2230-8407.04407]
2. Skoog DA, Holler FJ, Crouch SR, eds. Principles of instrumental analysis. Boston: Cengage Learning; 2017.
3. Bhardwaj SK, Dwivedia K, Agarwala D. A review: HPLC method development and validation. International Journal of Analytical and Bioanalytical Chemistry 2015;5:76-81.
4. Rajan H. Development and validation of HPLC method-A Review. International Journal of Current Research in Pharmacy 2015;1:55-68.
5. Gupta V, Jain ADKJ, Gill N, Guptan K. Development and validation of HPLC method-a review. International Research Journal of Pharmaceutical and Applied Sciences 2012;2:17-25.
6. Kumar V, Bharadwaj R, Gupta G, Kumar S. An Overview on HPLC Method Development, Optimization and Validation process for drug analysis. The Pharmaceutical and Chemical Journal 2015;2:30-40.
7. Rao BV, Sowjanya GN, Ajitha A, Rao VUM. A review on stability indicating HPLC method development. World J Pharm Pharm Sci 2015;4:405-23.
8. Sonia K, Nappinnai M. Development and validation of HPLC and UV-visible spectrophotometric method for the pharmaceutical dosage form and biological fluid-review. European Journal of Biomedical and Pharmaceutical Sciences 2016;3:382-91.
9. Nikolin B, Imamović B, Medanhodžić-Vuk S, Sober M. High perfomance liquid chromatography in pharmaceutical analyses. Bosn J Basic Med Sci 2004;4:5. [DOI:10.17305/bjbms.2004.3405]
10. Ahuja S. Overview of HPLC method development for pharmaceuticals. In: Ahuja S, ed. Separation science and technology. Vol. 8. Amsterdam: Elsevier; 2007. p. 1-11. [DOI:10.1016/S0149-6395(07)80007-9]
11. Ahuja S, ed. Chromatography and separation science. San Diego: Academic Press; 2003.
12. Ahuja S, Dong M, eds. Handbook of pharmaceutical analysis by HPLC. Amsterdam: Elsevier; 2005. [DOI:10.1016/S0149-6395(05)80045-5]
13. Kazakevich YV, Lobrutto R, eds. HPLC for pharmaceutical scientists. Hoboken: John Wiley & Sons; 2007. [DOI:10.1002/0470087951]
14. Mohammad T, Pandya K, Zaveri M, Sathe P. HPLC method development and validation for pharmaceutical analysis-A Review. International Pharmaceutica Sciencia 2012;2:14.
15. Patwekar S, Sakhare R, Nalbalwar N. HPLC method development and validation: a general concept. Int J Chem Pharm Sci 2015;6:8-14.
16. Jena A. HPLC: highly accessible instrument in pharmaceutical industry for effective method development. Pharm Anal Acta 2012;3:147 [DOI:10.4172/2153-2435.1000147]
17. McMaster MC, ed. LC/MS: a practical user's guide. Hoboken: John Wiley & Sons; 2005. [DOI:10.1002/0471736589]
18. Skoog DA, West DM, Holler FJ, Crouch SR, eds. Fundamentals of analytical chemistry. Boston: Cengage Learning; 2013.
19. Jeffery GH, Bassett J, Mendham J, Denney RC, eds. Vogel's textbook of quantitative chemical analysis. 5th ed. New York: John Wiley & Sons; 2022.
20. Chandrul Kaushal K, Srivastava B. A process of method development: A chromatographic approach. J Chem Pharm Res 2010;2:519-45.
21. Phani R, Prasad K, Reddy U. Scientific Approach for RP-HPLC Method Development: Complete Review. International Journal of Science Innovations and Discoveries 2012;2:218-28.
22. Rao G, Goyal A. An overview on analytical method development and validation by using HPLC. The Pharmaceutical and Chemical Journal 2016;3:280-9.
23. Yadav V, Bharkatiya M. A review on HPLC method development and validation. Res J Life Sci Bioinform Pharm Chem Sci 2017;2:178-87.
24. Snyder LR, Kirkland JJ, Glajch JL, eds. Practical HPLC method development. Hoboken: John Wiley & Sons; 2012.
25. Dong MW, ed. HPLC and UHPLC for practicing scientists. Hoboken: John Wiley & Sons; 2019. [DOI:10.1002/9781119313786]
26. Patil MPN. HPLC Method Development-A Review. Journal of Pharmaceutical Research and Education 2017;1(2):243-60.
27. Patnaik P, ed. Dean's analytical chemistry handbook. New York: McGraw-Hill Education; 2004.
28. Donald D, Mumtaz S. Development and validation of HPLC stability indicating assays. In: Huynh-Ba K, ed. Drug stability: principles and practices. 3rd ed. New York: Marcel Dekker; 2005. p. 329-84.
29. Christian GD, Dasgupta PK, Schug KA, eds. Analytical chemistry. Hoboken: John Wiley & Sons; 2013.
30. Faramarzi MA, Yazdi MT, Jahandar H, Amini M, Monsef-Esfahani HR. Studies on the microbial transformation of androst-1, 4-dien-3, 17-dione with Acremonium strictum. J Ind Microbiol Biotechnol 2006;33:725. [DOI:10.1007/s10295-006-0135-y]
31. de la Guardia M, Garrigues S, eds. Handbook of green analytical chemistry. Chichester: John Wiley & Sons; 2012. [DOI:10.1002/9781119940722]
32. Patel M, Patel D, Ahir K, Singh S. A Review: Development and validation of HPLC method. Journal of Pharmaceutical Science and Bioscientific Research 2019;9:173-82.
33. Chandra M, ed. A guide for the preparation and use of buffers in biological systems. San Diego: CALBIOCHEM, a brand of EMD Biosciences Inc, an affiliate of Merck KGaA, Darmstadt, Germany; 2003.
34. Reversed-phase H. Buffers: High Quality Buffers (solutions, solids or concentrates): available from: ccc. chem. pitt. edu/wipf/web/HPLC_RP_buffers. pdf. Accessed April. 2013;5.
35. Lindholm J, ed. Development and validation of HPLC methods for analytical and preparative purposes. Uppsala: Acta Universitatis Upsaliensis; 2004.
36. Sethi PD, ed. HPLC: quantitative analysis of pharmaceutical formulations. 1st ed. New Delhi: CBS Publishers & Distributors; 2012. P.1005.
37. Calderon LA, ed. Chromatography: the most versatile method of chemical analysis. Rijeka: IntechOpen; 2012. [DOI:10.5772/2707]
38. Moradpour Z, Torshabi M, Faramarzi MA, Tabatabaei Yazdi M, Ghasemi Y, Jahandar H, et al. Microalgal transformation of androst-4-en-3,17-dione by Nostoc ellipsosporum. Res J Microbiol 2006;1:289-93. [DOI:10.3923/jm.2006.289.293]
Send email to the article author

Add your comments about this article
Your username or Email:

CAPTCHA

XML   Persian Abstract   Print

Download citation:
BibTeX | RIS | EndNote | Medlars | ProCite | Reference Manager | RefWorks
Send citation to:
Alavi S M, Beheshti Maal A, Jahandar H. A review on high-performance liquid chromatography method design and development. MEDICAL SCIENCES 2025; 35 (3) :275-285
URL: http://tmuj.iautmu.ac.ir/article-1-2261-en.html
Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Volume 35, Issue 3 (Fall 2025) Back to browse issues page
فصلنامه علوم پزشکی دانشگاه آزاد اسلامی واحد پزشکی تهران Medical Science Journal of Islamic Azad Univesity - Tehran Medical Branch
Persian site map - English site map - Created in 0.05 seconds with 35 queries by YEKTAWEB 4718