Shweta Ubale, Mayur Bhosale, S. K. Parajne
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Shweta Ubale1*, Mayur Bhosale2, S. K. Parajne3
1Student, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni, Ahmednagar, Maharashtra, India.
2Professor, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni, Ahmednagar, Maharashtra, India.
3Professor, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni, Ahmednagar, Maharashtra, India.
Volume - 13,
Issue - 1,
Year - 2023
Aim of this study is to develop a new, precise, sensitive, simple, efficient, selective, and accurate high-performance liquid chromatographic method for the separation and determination of Deferiprone and its impurity in the capsule dosage form. A wide-range of literature survey disclosed no method for estimation said as the above. The chromatographic separation was achieved on Agilent Zorbax Bonus-RP (250 x 4.6mm, 5µ) with a mobile phase of Methanol: 0.1% O-Phosphoric acid (10:90, % v/v) combination in 1000ml of Methanol: Water (50: 50, % v/v) using a diluent. The flow rate of 1mL/min and UV detection at 280nm use as wavelength. The developed method was validated as reported by ICH guidelines. The linearity of the calibration curve for deferiprone and its process-related impurity in the concentration range of 4.0-6.0µg/ml. There exists a good correlation between peak area and analyte concentration. The retention time for deferiprone was discovered to be 2.29 min and its impurity was 8.65min. Deferiprone's relative standard deviation value is 0.45 and its process-related impurity is 0.17. All the results tell that the proposed method was highly sensitive, simple, precise, accurate, and fast. A large number of samples can be analyzed in a shorter time due to shorter retention times, so it can be successfully applied for routine analysis of Deferiprone and related impurity (maltol) in pharmaceutical dosage forms.
Cite this article:
Shweta Ubale, Mayur Bhosale, S. K. Parajne. Development and Validation of RP HPLC Method for Estimation of Deferiprone and its Related Impurityin Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(1):1-6. doi: 10.52711/2231-5675.2023.00001
Shweta Ubale, Mayur Bhosale, S. K. Parajne. Development and Validation of RP HPLC Method for Estimation of Deferiprone and its Related Impurityin Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2023; 13(1):1-6. doi: 10.52711/2231-5675.2023.00001 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-1-1
1. P. Vamsi Reddy, et.al., Stability indicating method development and validation of Deferiprone in pharmaceutical dosage form by RP-HPLC, Journal of Innovations in Pharmaceutical and Biological Sciences, Vol 4 (2), 53-57, 2017.
2. Thalassemia foundation of Canada.Thalassemia Major « Thalassemia. 2022.
3. FDA Approved Drug Products: Ferriprox (deferiprone) oral tablets;1-16;2011.https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021825s010lbl.pdf.
4. Federal Register International Conferences on Harmonization. Draft Revised guidance on Impurities in New Drug Substances, Q3A(R); 2000. p. 45085-90
5. Manzoor Ahmed, Vinod Kumar Jangade, et. al., RP-HPLC method development and validation for estimation of deferiprone in capsule dosage form. World Journal of Pharmacy and Pharmaceutical Science. 2015;831-838.
6. K. Sai Sireesha, et.al., A new RP-HPLC method development and validation of deferiprone in bulk and its pharmaceutical dosage form. International Journal of Advance Research. 2016;2174-2179.
7. Introduction to Food Toxicology A volume in Food Science and Technology Book; Chapter 7 - Food Contaminants from Industrial Wastes;1Pages 117-140.
8. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of Analytical Procedures: Text and Methodology ICH Q2 (R1); 2005.
9. Daksh S, Goyal A, Pandiya CK. Validation of analytical methodsstrategies and significance. Int J Res Dev Pharm Life Sci 2015; 4:1489-97
10. Guidance Document, Validation of Analytical Methods, Document ID IPC/GD/04 Version 1.0 Issue Date 16th September 2021;1-13.
11. ICH guidelines validation of analytical procedures; Text and methodology Q2 R1; 2005.
12. David A Armbruster. Limit of Blank, Limit of Detection and Limit of Quantitation; PubMed; National Library of Medicine; 2008 Aug; 29(Suppl 1): S49–S52.
13. United States Pharmacopeia (USP) 34 (NF 29), Chapter 621, Edition 2011.
14. European Medical Agency withdrawal assessment report of deferiprone; 2020;13-18; "UPKANZ, INN-deferiprone" (europa.eu).
15. Deferiproneimpurity, Pharmaffiliates.