Stability of amlodipine besylate and atenolol in multi-component tablets of mono-layer and bi-layer types

Acta Pharmaceutica

Volumn 58, Issue 3, 2008, Pages 299-308

  Aryal, Sajjan ^a,b   Škalko Basnet, Nataša ^a,c  

^a POKHARA UNIVERSITY   (Nepal)

^b Quest Pharmaceuticals (P) Ltd   (Nepal)

^c UNIVERSITY OF TROMSØ   (Norway)

Author keywords

Amlodipine; Atenolol; Bi layer tablet; Mono layer; Stability

Indexed keywords

AMLODIPINE BESYLATE; ATENOLOL;

ARTICLE; DRUG MIXTURE; DRUG PACKAGING; DRUG STABILITY; HUMIDITY; MATRIX TABLET; TABLET FORMULATION; THERMOSTABILITY;

EID: 53549110237     PISSN: 13300075     EISSN: None     Source Type: Journal    
DOI: 10.2478/v10007-008-0012-5     Document Type: Article

References (16)

1. S. Bangalore, G. Kamalakkannan, S. Parkar and F. H. Messerli, Fixed-dose combinations improve medication compliance: a meta-analysis, Am. J. Med. 120 (2007) 713-719; DOI: 10.1016/J.AMJMED. 2006.08.033.
2. A. V. Chobanian, G. L. Bakris, H. R. Black, W. C. Cushman, L. A. Green, J. L. Izzo Jr., D. W. Jones, B. J. Materson, S. Oparil, J. T. Wight Jr. and E. J. Rocella, Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure, Hypertension 42 (2003) 1206-1252.
3. L. Xu, F-M. Shen, H. Shu, C-Y. Miao, Y-Y. Jiang and D-F. Su, Synergism of atenolol and amlodipine on lowering and stabilizing blood pressure in spontaneously hypertensive rats, Fund. Clin. Pharmacol. 18 (2004) 33-38.
4. G. Ling, A-J. Liu, F-M. Shen, G-J. Cai, J-G. Liu and D-F. Su, Effects of combination therapy with atenolol and amlodipine on blood pressure control and stroke prevention in stroke-prone spontaneously hypertensive rats, Acta Pharmacol. Sin. 28 (2007) 1755-1760; DOI: 10.1111/j.1745-7254.2007. 00630.x.
5. G. Ragno, A. Garofalo and C. Vetuschi, Photodegradation monitoring of amlodipine by derivative spectrophotometry, J. Pharm. Biomed. Anal. 27 (2002) 19-24; DOI: 10.1016/S0731-7085(01)00556-8.
6. K. R. Naidu, U. N. Kale and M. S. Shingare, Stability indicating RP-HPLC method for simultaneous determination of amlodipine and benezepril hydrochloride from their combination drug product, J. Pharm. Biomed. Anal. 39 (2005) 147-155; DOI: 10.1016/J.JPBA.2005.04.001.
7. B. G. Chaudhari, N. M. Patel and P. B. Shah, Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products, Chem. Pharm. Bull. 55 (2007) 241-246.
8. A. Abdoh, M. M. Al-Omari, A. A. Badwan and A. M. Y. Jaber, Amlodipine besylate-excipients interaction in solid dosage form, Pharm. Dev. Technol. 9 (2004) 15-24; DOI: 10.1081/PDT-120027414.
9. V. Andrisano, R. Gotti, A. Leoni and V. Cavrini, Photodegradation studies on atenolol by liquid chromatography, J. Pharm. Biomed. Anal. 21 (1999) 851-857.
10. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Stability testing of new drug substances and products, Q1A(R2), Current step 4 version dated 6 February 2003; http://www.ich.org.
11. R. Klinkenberg, B. Streel and A. Ceccato, Development and validation of a liquid chromatographic method for the determination of amlodipine residues on manufacturing equipment surfaces, J. Pharm. Biomed. Anal. 32 (2003) 345-352; DOI: 10.1016/S0731-7085(03)00109-2.
12. K. Kamat and S. C. Chaturvedi, Stability indicating assay method for amlodipine tablets, Ind. J. Pharm. Sci. 67 (2005) 236-239.
13. M. C. F. Ferraro, P. M. Castellano and T. S. Kaufman, Chemometric determination of amiloride hydrochloride, atenolol, hydrochlorothiazide and timolol maleate in synthetic mixtures and pharmaceutical formulations, J. Pharm. Biomed. Anal. 34 (2004) 305-314; DOI: 10.1016/S0731-7085(03) 00521-1.
14. R. Ceresole, M. A. Moyano, M. T. Pizzorno and A. I. Segall, Validated reversed-phase HPLC method for the determination of atenolol in the presence of its major degradation product, J. Liq. Chromatogr. Rel. Tech. 29 (2006) 3009-3019; DOI: 10.1080/10826070600983393.
15. R. K. Barman, M. A. Islam, M. Ahmed, M. I. Ibne Wahed, R. Islam, A. Khan, M. B. Hossain and B. M. Rahman, Simultaneous high-performance liquid chromatographic determination of atenolol and amlodipine in pharmaceutical- dosage form, Pak. J. Pharm. Sci. 20 (2007) 274-279.
16. A. P. Argekar and S. G. Powar, Simultaneous determination of atenolol and amlodipine in tablets by high performance thin-layer chromatography, J. Pharm. Biomed. Anal. 21 (2000) 1137-1142.