Author(s): Shaleena Munwar, Appala Anjali, PSS Prasanna Kumar, B Prem Kumar

Email(s): pharmacy.shaleena@gmail.com

DOI: 10.52711/2231-5675.2026.00018   

Address: Shaleena Munwar1*, Appala Anjali2, PSS Prasanna Kumar2, B Prem Kumar2
1Mahathi College of Pharmacy, Madanapalli, Jntua, Andhra Pradesh- 517319, India.
2A.K.R.G College of Pharmacy, Nallajerla, Jntuk, Andhra Pradesh -534112, India.
*Corresponding Author

Published In:   Volume - 16,      Issue - 2,     Year - 2026


ABSTRACT:
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Vadadustat in pharmaceutical dosage form. Chromatographic separation of Vadadustat was achieved on Waters Alliance-e2695, by using Inertsil ODS, 150x4.6mm, 3.5µ column and the mobile phase containing Acetonitrile and 0.1% Formic acid in the ratio of 20:80% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 234nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Vadadustat were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Vadadustat.


Cite this article:
Shaleena Munwar, Appala Anjali, PSS Prasanna Kumar, B Prem Kumar. Analytical Method Development and Validation of Vadadustat in Bulk and Pharmaceutical Dosage Forms by Using RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2026; 16(2):119-2. doi: 10.52711/2231-5675.2026.00018

Cite(Electronic):
Shaleena Munwar, Appala Anjali, PSS Prasanna Kumar, B Prem Kumar. Analytical Method Development and Validation of Vadadustat in Bulk and Pharmaceutical Dosage Forms by Using RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2026; 16(2):119-2. doi: 10.52711/2231-5675.2026.00018   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2026-16-2-8


REFERENCES: 
1.    Pergola PE, Spinowitz BS, Hartman CS, Maroni BJ, Haase VH. Vadadustat, a novel oral HIF prolyl hydroxylase inhibitor, provides effective anemia treatment in nondialysis-dependent chronic kidney disease. Kidney Int. 2016; 90(5): 1115–1122.
2.    Martin ER, Smith MT, Maroni BJ, Zuraw QC, deGoma EM. Clinical trial of vadadustat in patients with anemia secondary to CKD. N Engl J Med. 2021; 384(17): 1601–1612.
3.    Choi D, Park S, Lee J, Kim M, Park H, et al. Pharmacokinetics and safety of vadadustat in healthy subjects. Clin Transl Sci. 2019; 12(4): 370–376.
4.    Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating methods—A critical review. J Pharm Anal. 2014; 4(3): 159–165.
5.    International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology. Geneva: ICH; 2005.
6.    Snyder LR, Kirkland JJ, Dolan JW. Introduction to Modern Liquid Chromatography. 3rd ed. Hoboken, NJ: John Wiley & Sons; 2010.
7.    Dong MW. Modern HPLC for Practicing Scientists. Hoboken, NJ: John Wiley and Sons; 2006.
8.    Meyer VR. Practical High-Performance Liquid Chromatography. 5th ed. Chichester: Wiley; 2010.
9.    USFDA. Bioanalytical Method Validation Guidance for Industry. U.S. Food and Drug Administration; 2018.
10.    European Medicines Agency (EMA). Guideline on Bioanalytical Method Validation. EMA, 2011.


Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 


Recent Articles




Tags