A review on experimental designs in hplc method development and validation

Supriya K; Asma Parveen S; Prapurna Chandra Y

doi:10.37022/jiaps.v10i1.655

K.Supriya B. Pharmacy, IV Year, Ratnam Institute of Pharmacy, spsr Nellore, Andhra Pradesh.
S. Asma Parveen Associate professor, Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, spsr Nellore, Andhra Pradesh.
Y. Prapurna Chandra Principal of Ratnam Institute of Pharmacy, spsr Nellore, Andhra Pradesh.

DOI https://doi.org/10.37022/jiaps.v10i1.655

Abstract

The development and validation of High-Performance Liquid Chromatography (HPLC) methods are critical steps in ensuring the accurate, reliable, and reproducible quantification of analytes in various matrices. This study outlines a systematic approach to HPLC method development and validation, including the selection of appropriate stationary and mobile phases, optimization of chromatographic conditions, and evaluation of method performance. The developed method demonstrated excellent performance with linear calibration curves (R²>. 0.999), high precision (%RSD < 2%), and recoveries reliability under slight variations in analytical conditions. These findings confirm the suitability of the method for routine analysis in pharmaceutical, clinical, or industrial applications. Every day many chromatographers face the need to develop a high-performance liquid chromatography (HPLC) method. This review describes systematic procedures for developing an HPLC method, based on the best information available. HPLC method development involves several essential steps: sample pretreatment, detection of sample bands, choosing separation conditions, quantitation, and method validation. HPLC is an analytical tool which is able to detect, separate and quantify the drug, its various impurities and drug related degrades that can form on synthesis or storage. This article describes strategies & an issue comes in development of a HPLC method development & validation.

Keywords: High-performance liquid chromatography [HPLC] Method development, Method validation, Analytical techniques, Chromatography analysis

Downloads

Download data is not yet available.

References

1. Rao BV, Sowjanyal GN, Ajitha A, Uma V, Rao M. A review on stability indicating HPLC method development. World Journal of Pharmacy and Pharmaceutical Sciences 2015;4(8)405-423.
2. Rasaiah JC. Molecular Theory of Solutions by Arieh Ben-Naim (The Hebrew University, Jerusalem, Israel). Oxford University Press: Oxford, New York. 2006. xviii + 380 pp. $64.50. ISBN: 0-19-929970 6. Journal of the American Chemical Society 2007;129(28):8922 8922.
3. Priya Saraha, Kavita Dhamma. High-performance Liquid Chromatography Method Development and Validation. International journal of pharmaceutical sciences review and research; 2022; vol 2; 23.
4. Hearn M.T.W. Ion-pair chromatography on normal and reversed-phase systems. Adv. Chromatogram. 1980; 18: 59–100
5. Gupta V, Jain A D, Gill N S, Gupta K. Development and validation of HPLC method - a review. International Research Journal of Pharmaceutical and Applied Sciences. 2012; 2(4):17-25..
6. . Mcpolin Oona. An Introduction to HPLC for Pharmaceutical Analysis. Mourne Training Service. 11-12.
7. Dhirendra Kumar Mehta, Mahato Ashok Kumar, Koiri Sonali. HPLC Method Development and Validation. World journal of pharmaceutical and medical research. 2024; vol 10; 234.
8. Liu Y., Lee M. L. Ultrahigh pressure liquid chromatography using elevated temperature. Journal of Chromatography. 2006; 1104 (1-2): 198–202.
9. Gita Chawla1 Krishna Kr. Chaudhary2. A review of HPLC technique covering its pharmaceutical, environmental, forensic, clinical and other applications. International Journal of Pharmaceutical Chemistry and Analysis, April-June, 2019;6(2):27-39
10. Shrivastava, M.M. An overview of HPLC: A Morden Analytical technique with Excellent Potential for automation, Optimization, Hyphenation, and Multidimensional application. in: Shrivastava, M.M HPLC. New You: Springer, pp.3-24
11. Charde, M. S., Chakola, M. D., Lewanika, A. S., Keshwar, U., Shrikanta, B. K., Development of validated HPTLC method for the estimation of eugenol in marketed herbal formulation of muscle and joint HRX pain relieving oil, International Journal of Phyto pharmacy Research Article.2014,4 (1), 28-32
12. Sonia K*, Bedi Bhavya Shree, Dr .K.S. Lakshmi HPTLC Method Development and Validation. Sonia K et al /J. Pharm. Sci. 2017; 9(5): 652-657.
13. Snyder LR, Kirkland JJ, Glajch JL. Practice HPLC method development, 2nd edition. New York. John Wiley. 1997; 16
14. Bliesner D.M., Validating Chromatographic Methods, john Wiley & sons, Inc. 2006; 88- 92
15. Vijendra, H. Rajan. Development and validation of HPLC method - A Review, International Journal of current research in pharmacy. 2015; 1(2):55-6
16. Dhara. K. Patel, Mrs. Mitali Dalwadi A Review on High Performance Liquid Chromatography. A Review on High Performance Liquid Chromatography. 2023, 8[1]: 2531-2535.
17. Hearn MTW. Ion-pair chromatography on normal and reversed-phase systems. Advance Chromatography. 1980; 18: 59–100.
18. Abdu Hussen, Ali High-Performance Liquid Chromatography (HPLC): 20, 2022.