Author(s):
Shivaji Jadhav, Gajanan Mandawad, Namdeo Dhokale, Shankaraiah Konda
Email(s):
kondasg@rediffmail.com
DOI:
10.52711/0974-4150.2025.00050
Address:
Shivaji Jadhav1,2, Gajanan Mandawad2, Namdeo Dhokale3, Shankaraiah Konda3*
1Indoco Remedies Ltd., TTC Industrial Area, Rabale, Navi Mumbai - 400701, Maharashtra.
2Department of Chemistry, Maharashtra Udaygiri College, Udgir - 413517, Maharashtra.
3Research Center in Chemistry, K. J. Somaiya College, Kopargaon - 423601, Maharashtra.
*Corresponding Author
Published In:
Volume - 18,
Issue - 5,
Year - 2025
ABSTRACT:
The four impurities in Brimonidine Tartrate bulk drug substances were detected by newly developed gradient reverse phase high performance liquid chromatography (HPLC) method. These impurities were named as Brimonidine Impurity- A, B, C, and D. The Brimonidine Impurity-A, Brimonidine Impurity-B, Brimonidine Impurity-C were process impurities, while Brimonidine Impurity-D is degradation impurity. The degradation Brimonidine Impurity-D was isolated by semi preparative HPLC. Structural elucidation of unknown impurities was carried out by means of (conformed by) spectral studies like IR, NMR and Mass synthesized authentic compounds.
Cite this article:
Shivaji Jadhav, Gajanan Mandawad, Namdeo Dhokale, Shankaraiah Konda. Isolation, Characterization of Unknown Impurity in Brimonidine Tartrate by Auto Purifier, NMR, LC/MS/MS and HPLC. Asian Journal of Research in Chemistry. 2025; 18(5):327-0. doi: 10.52711/0974-4150.2025.00050
Cite(Electronic):
Shivaji Jadhav, Gajanan Mandawad, Namdeo Dhokale, Shankaraiah Konda. Isolation, Characterization of Unknown Impurity in Brimonidine Tartrate by Auto Purifier, NMR, LC/MS/MS and HPLC. Asian Journal of Research in Chemistry. 2025; 18(5):327-0. doi: 10.52711/0974-4150.2025.00050 Available on: https://ajrconline.org/AbstractView.aspx?PID=2025-18-5-5
6. REFERENCES:
1. Cambridge D, A potent and selective α2-agonist for the characterization of -adrenoceptor subtypes. Eur. J. Pharmacol., 1981; 72:413-415.
2. Jiang S, Chappa AK, Proksch JW, A rapid and sensitive LC-MS/MS assay for the quantitation of Brimonidine in ocular fluids and tissues. J Chromatogr B Ana. Tech. Biomed Life Sci. 2009; 877(3): 107-14.
3. Acheampong A, Tang-Liu DD, Measurement of brimonidine concentrations in human plasma by a highly sensitive gas chromatography/mass spectrometric assay. J. Pharm. Biomed. Anal. 1995; 13(8):995-1002
4. Blessy M, Patel RD, Prajapati PN, Agrawal YK, Development of forced degradation and stability indicating studies of drugs—a review. J. Pharm. Anal. 2014; 4(3):159-165.
5. Morrison JC, Elevated intraocular pressure and optic nerve injury models in the rat. J. Glaucoma., 2005; 14(4):315-17.
6. Burke J, Schwartz M, Preclinical evaluation of brimonidine Surv. Ophthalmol. 1996; 41(S1), S9-S18
7. Ethier RC, Johnson M, Ruberti J, Ocular biomechanics and biotransport. Annu Rev Biomed Eng, 2004; 6:249-73.
8. Mahajan M, Tiwari R, Method Development and Validation of Brimonidine Tartrate by High Performance Liquid Chromatography. Asian J. Research Chem. 2011; 4(10): 1591-1593
9. Mussie EW, Ruiz G, Wijono M, Wheeler LA, Neuroprotection of retinal ganglion cells by brimonidine in rats with laser-induced chronic ocular hypertension. Investig. Ophthalmol. Vis. Sci., 2001; 42(12):2849-2855