Author(s):
H. S. Jumde, S. D. Mankar
Email(s):
sdmankar655@gmail.com
DOI:
10.52711/2231-5713.2022.00030 
Address:
H. S. Jumde1*, S. D. Mankar2
1Department of Quality AssuranceTechnique, Pravara Rural College of Pharmacy, Loni, 413736, India.
2Department of Pharmaceutics, Pravara Rural College of Pharmacy, Loni, 413736, India.
*Corresponding Author
Published In:
Volume - 12,
Issue - 2,
Year - 2022
ABSTRACT:
RP-HPLC is the most, sensitive, universal analytical procedure. It is extremely versatile tech where analytes are separated by passes through column of different sized particles. Analytical method development ensures the specific characteristics of the drug substances against the preconceived acceptance criteria, while method meets objectives required at each stage of development of drug which is a continuous process, and should be robust and accessible. Validation of analytical method demonstrates the scientific firmness of measurement or characterization and is required throughout the regulatory submission process and the main purpose of validation of API is to demonstrate that it maintains the desired level of compliance and also suitable for its intended purpose.
Cite this article:
H. S. Jumde, S. D. Mankar. Review on development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography. Asian Journal of Pharmacy and Technology. 2022; 12(2):179-2. doi: 10.52711/2231-5713.2022.00030
Cite(Electronic):
H. S. Jumde, S. D. Mankar. Review on development of Analytical Method and Validation by Reverse Phase – High Performance Liquid Chromatography. Asian Journal of Pharmacy and Technology. 2022; 12(2):179-2. doi: 10.52711/2231-5713.2022.00030 Available on: https://www.ajptonline.com/AbstractView.aspx?PID=2022-12-2-16
REFERENCES:
1. HEMA, G. Swetha Reddy, 2017. A Review on New Analytical Method Development and Validation Using RP-HPLC, et al.
2. Method development and validation of pharmaceuticals by different instrumental techniques: a review by Sabyasachi Biswal Sumanta mondal, H K Sandep Kumar, International Journal of Pharmaceutical Science Reviews and Research. 2018.
3. Akul Mehta (Dec 27, 2012). Principle of reverse-phase chromatography HPLC/UPLC. Pharmaxchange. Retrieved 10 Jan 2013.
4. Amersham Biosciences. Reverse Phase Chromatography Principles and Methods. page 9-10.
5. R.E Majors, LCGC 15 (11), 1008-1015 (1997).
6. Ronald E. Majors, Agilent Technologies, Wilmington Delaware, USA, The cleaning and regeneration of reverse phase HPLC column, LC.GC Europe (Jul 2003)
7. Snyder LR, Kirkland JJ, Glajch JL: Practical HPLC method development. 2nd ed. 2001.
8. Kar A: pharmaceutical Drug analysis. 1st edition 2001; 565-592.
9. Amesham bioscience: reverse phase chromatography. Principles and methods, page. 6-8.
10. Sethi PD: HPLC Quantitative Analysis of Pharmaceutical Formulation. CBS Publishers and Distributors, 1st edition 2001.