Authors :
Dr. R. K. Sangeetha; S. Shimna; K. Hifathulla; A. Rohith Kannan
Volume/Issue :
Volume 11 - 2026, Issue 10 - October
Google Scholar :
https://tinyurl.com/e6e93jhp
DOI :
https://doi.org/10.38124/ijisrt/26Oct1016
Note : A published paper may take 4-5
working days from the publication date to appear in PlumX Metrics, Semantic Scholar, and
ResearchGate.
Abstract :
A simple, rapid and sensitive ultra-fast liquid chromatographic technique was developed for the determination of heavy metals in pharmaceutical dosage form. Lead and copper were detected and quantified at µg level in simvastatin, a pharmaceutical product used in the treatment of lowering cholesterol level in body. Calcium disodium edetate was used as the chelating agent.
Keywords :
UFLC-PDA, Method Validation, Simvastatin, Lead Nitrate, Copper Sulphate, ICH Guidelines.
References :
- Tchounwou PB., Yedjou CG., Patlolla AK., Sutton DJ.: Heavy metal toxicity and the environment. Exp Suppl. 2012, 101:133-64.
- Engwa GA., Ferdinand PU., Nwalo FN., Unachukwu MN.: Mechanism and health effects of heavy metal toxicity in humans. Poisoning in the modern world-new tricks for an old dog. 2019, 19(6), 10:70-90.
- U.S. National Library of Medicines, National center for biotechnology information, Available at https://pubchem.ncbi.nlm.nih.gov/compound/Lead-nitrate. Access date- 05 Apr 2023.
- Balali-Mood M., Naseri K., Tahergorabi Z., Khazdair MR., Sadeghi M.: Toxic Mechanisms of Five Heavy Metals: Mercury, Lead, Chromium, Cadmium, and Arsenic. Front Pharmacol. 2021,13(4), 12:643972.
- U.S. National Library of Medicines, National center for biotechnology information, Available at https://pubchem.ncbi.nlm.nih.gov/compound/Copper-Sulfate. Access date-05 Apr 2023.
- LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Copper. [Updated 2017 Oct 30]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK548090/
- U.S. National Library of Medicines, National center for biotechnology information, Available at https://pubchem.ncbi.nlm.nih.gov/compound/Calcium-disodium-edetate. Access Date- 05 Apr 2023.
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf. Access date- 05 Apr 2023.
- Flora SJ., Pachauri V.: Chelation in metal intoxication. Int. J. Environ. Res. Public Health., 2010,7(7), 2745-88.
- U.S. National Library of Medicines, National center for biotechnology information, Available at https://pubchem.ncbi.nlm.nih.gov/compound/Simvastatin. Access date- 05 Apr 2023.
- Talreja O., Kerndt CC., Cassagnol M.: Simvastatin, [Updated 2022 Jun 6], In: StatPearls [Internet], Treasure Island (FL), StatPearls Publishing, 2023 Jan, Available from: https://www.ncbi.nlm.nih.gov/books/NBK532919/
- Birari AE.: Development and Validation of UV-Spectrophotometric Method for Estimation of Simvastatin in Bulk and Solid Dosage Form. Int. J. of Pharma Sci., 2015, 6(1), 185-89.
- Munir A., Ahmad M., Malik MZ., Minhas MU.: Analysis of simvastatin using a simple and fast high-performance liquid chromatography-ultra violet method development, validation and application in solubility studies. Tropical Journal of Pharmaceutical Research., 2014, 13(2), 135-9.
- Chavhan V., Ghante M., Sawant S.: Development and validation of RP-HPLC method for simultaneous estimation of sitagliptin phosphate and simvastatin in bulk and tablet dosage form. J App Pharm., 2014, 6(3), 327-38.
- Sangeetha.R.K.: Study of Chelate Complex of Heavy Metals with Calcium Disodium Versenate and Methanolic Extract of Carica Papaya Leaves by UV Spectroscopy. IAR J Pharm., 2021, 30(4), 10-15.
- Sethi PD., Sethi's HPLC: High-Performance Liquid Chromatography: Quantitative Analysis of Pharmaceutical Formulations. CBS; 2010. pp.17-19.
- Chatwal G., and Anand S.: Instrumental method of Chemical Analysis: (analytical chemistry), 3rd edition; ISBN No.:978-93-5142-088-0, Himalaya Publishing House, New Delhi, 2016, pp.2624-2639.
- Validation of Analytical Procedures: Text and methodology Q2 (R1), ICH Harmonized Tripartite Guidelines, 2005, 1-12.
A simple, rapid and sensitive ultra-fast liquid chromatographic technique was developed for the determination of heavy metals in pharmaceutical dosage form. Lead and copper were detected and quantified at µg level in simvastatin, a pharmaceutical product used in the treatment of lowering cholesterol level in body. Calcium disodium edetate was used as the chelating agent.
Keywords :
UFLC-PDA, Method Validation, Simvastatin, Lead Nitrate, Copper Sulphate, ICH Guidelines.