Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC in Pharmaceutical Dosage Forms Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC
Iranian Journal of Pharmaceutical Sciences,
Vol. 16 No. 1 (2020),
15 January 2020
,
Page 19-28
https://doi.org/10.22037/ijps.v16.40442
Abstract
The purpose of this study is Acamprosate Calcium synthesis of 3-Aminopropane-1-sulfonic acid (Homotaurine) and validation of assay test in the delayed-release tablets by HPLC without organic solvents. The
assay method by HPLC was found to be linear in the concentration range of 50 to 200 μg/mL. Successful separation was achieved by isocratic elution on a Phenomenex® C18 column (250 mm × 4.6 mm, 5μm).The mobile phase was triethylammonium phosphate buffer pH: 4.0 (100%) at the flow rate of 1 mL/min using UV detection at 210 nm, column oven temperature 25ºC and injection volume 20
Keywords:
- Synthesis
- Evaluation
- Acamprosate Calcium
- RP-HPLC
- Method development
- Pharmaceutical
How to Cite
Rezaei, M. ., Ramazani, A. ., & Gouranlou, F. . (2020). Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC in Pharmaceutical Dosage Forms: Synthesis and Purification of Acamprosate Calcium and its Evaluation by RP-HPLC. Iranian Journal of Pharmaceutical Sciences, 16(1), 19–28. https://doi.org/10.22037/ijps.v16.40442
References
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[13] Chabenat C, Ladure P, Blanc-Continsouza D, Boismare F, Boucly P. Determination of calcium acetylhomotaurinate by liquid chromatography with fluorimetric and electrochemical detection. J. Chromatogr. B Biomed. Sci. Appl. (1987) 414: 417-422.
[14] Ghosh C, Jha V, Shinde C. P, Chakraborty B. S. A LC‐MS analysis of acamprosate from human plasma: pharmacokinetic application. Drug Test Anal. (2011) 3 (10): 735-742.
[15] Girault J, Gobin P, Fourtillan J. Determination of calcium acetylhomotaurinate in human plasma and urine by combined gas chromatography-negative-ion chemical ionization mass spectrometry. J. Chromatogr. B. Biomed. Sci. Appl. (1990) 530: 295-305.
[16] Kanala K. M, Chandu B. R, Hwisa N. T, Khagga M, Katakam P, Challa B. Quantification of Acamprosate in human plasma by LC-ESI-MS/MS with solid phase extraction: Application to a bioequivalence study. J. Pharm. Res. (2013) 7 (5): 389-396.
[17] Rhee, Y.-S, et al. Analysis of acamprosate in beagle dog plasma by LC-MS-MS. Arch. Pharm. Res. (2008) 31 (8): 1035-1039.
[2] Mason B. J, Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J. Clin. Psychiatry (2001) 62: 42-48.
[3] Saivin S, Hulot T, Chabac S, Potgieter A, Durbin P, Houin G. Clinical pharmacokinetics of acamprosate. Clin. Pharmacokinet (1998) 35 (5): 331-345.
[4] Rhee Y.-S, et al. Investigation of the relationship between in vitro and in vivo release behaviors of acamprosate from enteric-coated tablets. Arch. Pharm. Res. (2008) 31 (6): 798-804.
[5] Aseervadamma M, Babu C. A, Ramanjaneyulu K, Kumar J. S, Basha M. Method Development & Validation of Acamprosate Tablet Dosage Form by RP-HPLC. World J. Pharm. Pharm. Sci. (2014) 3 (12): 984-994.
[6] Babua C, Sreenivasa Rao B, Suresh Reddy K, Naganjaneyulu B. Development and Validation of HPLC Assay Method for the Acamprosate Ca in Commercial Tablets. IJACS. (2013) 2 (1): 46-49.
[7] Bharghavi L, Maheshwari M, Kartheek N.; Kumar A. A. Rp-Hplc Method Development And Validation For The Quantitative Estimation Of Acamprosate Calcium In Tablets. Int. J. Pharm. Pharm. Sci. (2014) 6 (6): 582-85.
[8] Thangabalan B, Koya A, Chaitanya G, Sunitha N, Babu S. M. Stability Indicating RP–HPLC Method for the Estimation of Acamprosate in Pure and Tablet Dosage Form. AJPA. (2013) 3 (4): 141-146.
[9] Kirankumar A, Mamatha B, Sasikala M, Monika S, Ranganayakulu D. Validated UV spectrophotometric method development and stability studies of acamprosate calcium in bulk and tablet dosage form. Int. J. Pharmtech. Res. (2013) 5 (3): 1241-1246.
[10] Blanchin M.-D, Baalbaki B, Bosc N, Fabre H. Short-end injection technique in capillary electrophoresis for dissolution testing of tablets. Anal. Chim. Acta (2000) 415 (1-2): 67-73.
[11] Fabre H, Blanchin M, Bosc N. Capillary electrophoresis for the determination of bromide, chloride and sulfate as impurities in calcium acamprosate. Anal Chim Acta (1999) 381 (1): 29-37.
[12] Fabre H, Perrin C, Bosc N. Determination of homotaurine as impurity in calcium acamprosate by capillary zone electrophoresis. J. Chromatogr. A (1999) 853 (1-2): 421-430.
[13] Chabenat C, Ladure P, Blanc-Continsouza D, Boismare F, Boucly P. Determination of calcium acetylhomotaurinate by liquid chromatography with fluorimetric and electrochemical detection. J. Chromatogr. B Biomed. Sci. Appl. (1987) 414: 417-422.
[14] Ghosh C, Jha V, Shinde C. P, Chakraborty B. S. A LC‐MS analysis of acamprosate from human plasma: pharmacokinetic application. Drug Test Anal. (2011) 3 (10): 735-742.
[15] Girault J, Gobin P, Fourtillan J. Determination of calcium acetylhomotaurinate in human plasma and urine by combined gas chromatography-negative-ion chemical ionization mass spectrometry. J. Chromatogr. B. Biomed. Sci. Appl. (1990) 530: 295-305.
[16] Kanala K. M, Chandu B. R, Hwisa N. T, Khagga M, Katakam P, Challa B. Quantification of Acamprosate in human plasma by LC-ESI-MS/MS with solid phase extraction: Application to a bioequivalence study. J. Pharm. Res. (2013) 7 (5): 389-396.
[17] Rhee, Y.-S, et al. Analysis of acamprosate in beagle dog plasma by LC-MS-MS. Arch. Pharm. Res. (2008) 31 (8): 1035-1039.
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