Development of capillary electrophoresis technique for simultaneous measurement of amlodipine and atorvastatin from their combination drug formulations

Journal of Liquid Chromatography and Related Technologies

Volumn 32, Issue 20, 2009, Pages 2923-2942

  Hefnawy, Mohamed M ^a   Sultan, Maha ^a   Al Johar, Haya ^a  

^a KING SAUD UNIVERSITY   (Saudi Arabia)

Author keywords

Amlodipine; Atorvastatin; Capillary electrophoresis; Diode array detector

Indexed keywords

AMLODIPINE; APPLIED VOLTAGES; ATORVASTATIN; BACKGROUND ELECTROLYTES; DEGRADATION PRODUCTS; DIODE ARRAY DETECTORS; DRUG FORMULATIONS; FUSED-SILICA CAPILLARIES; INTERNAL STANDARDS; LIMITS OF DETECTION; LOSARTAN; PERCENTAGE RECOVERY; PHOSPHATE BUFFERS; SIMULTANEOUS DETERMINATIONS; SIMULTANEOUS MEASUREMENT; TABLET FORMULATIONS;

AMPLITUDE MODULATION; CAPILLARY ELECTROPHORESIS; DEGRADATION; DIODES; ELECTROCHEMISTRY; FUSED SILICA; METHANOL; SEPARATION; SILICA;

DETECTORS;

AMLODIPINE; AMLODIPINE PLUS ATORVASTATIN; ATORVASTATIN; LOSARTAN;

ARTICLE; CAPILLARY ELECTROPHORESIS; CONTROLLED STUDY; DIODE; DRUG ANALYSIS; DRUG DEGRADATION; DRUG DETERMINATION; DRUG FORMULATION;

EID: 71949105678     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070903320681     Document Type: Article

References (45)

1. Budavari, S. The Merck Index, an Encyclopedia of Chemicals, Drugs, and Biologicals, 13th Ed.; Merck & Co. Inc.: Whitehouse Station, NJ. 2001; 86-87.
2. McEvoy, G.K. American Hospital Formulary Service1, American Society of Health System Pharmacists Inc, Bethedsa 2001, 488, 865-876.
3. Goodman, A.G.; Gilman, L.S. In The Pharmacological Basis of Therapeutics, 8th Ed.; Gilman, A.G., Rall, A.S., Nies, P. Taylor, Eds.; Pergamon Press: Oxford: 2004, 774.
4. Sweetman, S. Martindale the Complete Drug Reference; 34th Ed.; Pharmaceutical Press: London 2005; 862-866.
5. Fakhari, R.; Nojavan, S.; Haghgoo, S.; Mohammadi, A. Development of a stability-indicating CE assay for the determination of amlodipine enantiomers in commercial tablets. Electrophoresis 2008, 29, 4583-4592.
6. Dalmora, L.; Sangoi, S.; Dasilva, M.; Macedo, O.; Barth, T. Validation of a capillary zone electrophoresis method for the comparative determination of etoricoxib in pharmaceutical formulations. J. Sep. Sci. 2008, 31, 169-176.
7. Mohammadi, A.; Kanfer, I.; Walker, B. A capillary zone electrophoresis (CZE) method for the determination of cyclizine hydrochloride in tablets and suppositories J. Pharm. Biomed. Anal. 2004, 35, 233-239.
8. ICH, Q1A Stability Testing of New Drug Substances and Products, In: Proceeding of the International Conference on Harmonization, Geneva, October 1993.
9. ''The United States Pharmacopoeia,'' 26th Ed.; US Pharmacopoeial Convention: Rockville, MD, 2003; 1151.
10. ''The European Pharmacopoeia,'' 4th Ed.; Council of Europe: Cedex, France. 2002; 639-640.
11. Zarghi, A.; Shafaati, A.; Foroutan, M.; Khoddam, A. A simple and rapid HPLC method for the determination of atorvastatin in human plasma with UV detection and its application to pharmacokinetic studies. Arzneim.- Forsch. 2005, 55, 451-454. (Pubitemid 41190747)
12. Koytchev, R.; Ozalp, Y.; Erenmemisoglu, A.; VanderMeer, M.; Alpan, R. Bioequivalence study of atorvastatin tablets. Arzneim.-Forsch. 2004, 54, 573-577.
13. Bahrami, G.; Mohammadi, B.; Mirzaeei, S.; Kiani, A. Determination of atorvastatin in human serum by reversed-phase high-performance liquid chromatography with UV detection. J. Chromatogr. B 2005, 826, 41-45. (Pubitemid 41446432)
14. Hermann, M.; Christensen, H.; Reubsaet, L. Determination of atorvastatin and metabolites in human plasma with solid-phase extraction followed by LC-tandem MS. Anal. Bioanal. Chem. 2005, 382, 1242-1249.
15. Jema, M.; Ouyang, I.Z.; Chen, C.; Teitz, D. Quantitation of the acid and lactone forms of atorvastatin and its biotransformation products in human serum by high-performance liquid chromatography with electrospray tandem mass spectrometry. Rapid. Commun. Mass Spectrom 1999, 13, 1003-1015.
16. Bullen, W.; Mille, R. Development and validation of a high-performance liquid chromatography-tandem mass spectrometry assay for atorvastatin, ortho-hydroxyatorvastatin and para-hydroxyatorvastatin in human, dog and rat plasma. J. Am. Soc. Mass Spectrom 1999, 10, 55-66.
17. Erturk, S.; Sevinc, E.; Ersoy, L.; Ficicioglu, S. An HPLC method for the determination of atorvastatin and its impurities in bulk drug and tablets. J. Pharm. Biomed. Anal. 2003, 33, 1017-1023.
18. Pasha, K.; Muzeeb, S.; Basha, J.; Shashikumar, D.; Mullangi, R.; Srinivas, R. Analysis of five HMG-CoA reductase inhibitors-atorvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin: pharmacological, pharmacokinetic and analytical overview and development of a new method for use in pharmaceutical formulations analysis and in vitro metabolism studies. Biomed. Chromatogr. 2006, 20, 282-293.
19. Ramakrishna, N.; Koteshwara, M.; Vishwottam, K.; Puran, S.; Manoj, S.; Santosh, M. Simple, sensitive and rapid LC-MS=MS method for the quantitation of cerivastatin in human plasma - application to pharmacokinetic studies. J. Pharm. Biomed. Anal. 2004, 36, 505-515.
20. Khopade, A.; Jain, K. Difference spectrophotometric estimation of amlodipine besylate. Indian Drugs 2000, 37, 351-353.
21. Bahrami, G.; Mirazaeei, H. Simple and rapid HPLC method for determination of amlodipine in human serum with fluorescence detection and its use in pharmacokinetic studies. J. Pharm. Biomed. Anal. 2004, 36, 163-168. (Pubitemid 39209420)
22. Streel, B.; Laine, C.; Zimmer, C.; Sibenaler, R. Enantiomeric determination of amlodipine in human plasma by liquid chromatography coupled to tandem mass spectrometry. J. Biochem. Biophy. Methods 2002, 54, 357-368.
23. Patki, V.; Tamhankar, P.; Tipnis, P. Simple and rapid high-performance liquid chromatographic estimation of amlodipine from pharmaceutical dosages. Indian Drugs 1994, 31, 560-561.
24. Avadhanulu, A.; Srinivas, S.; Anjaneyulu, Y. Reverse phase HPLC determination of amlodipine besylate in drug and pharmaceutical dosage forms. Indian Drugs 1996, 33, 36-40.
25. Zarapkar, S.; Kotle, S.; Rane, H. High-performance liquid-chromatographic determination of amlodipine and atenolol, simultaneously from pharmaceutical preparations. Indian Drugs 1997, 34, 350-353.
26. Zarapkar, S.; Kanyawar, S. Simultaneous estimation of amlodipine and losartan potassium in pharmaceutical dosage by reversed phase high performance liquid chromatography. Indian Drugs 2002, 39, 338-341. (Pubitemid 34918702)
27. Altiokka, G.; Altiokka, M. Flow-injection analysis of amlodipine using UV detection. Pharmazie 2002, 57, 500-503.
28. Pandya, K.; Satia, M.; Gandhi, P.; Modi, A. Detection and determination of total amlodipine by high-performance thin-layer chromatography: a useful technique for pharmacokinetic studies. J. Chromatogr. B 1995, 667, 315-320.
29. Chandrashekhar, G.; Rao, N.; Smrita, K.; Vyas, K. Analysis of amlodipine besylate by HPTLC with fluorimetric detection: a sensitive method for assay of tablets. J. Planner Chromatogr. 1994, 7, 458-460.
30. Naidu, K.; Kale, N.; Shingare, S. Stability indicating RP-HPLC method for simultaneous determination of amlodipine and benazepril hydrochloride from their combination drug product. J. Pharm. Biomed. Anal. 2005, 39, 147-155.
31. Rojas, F.; Ojeda, C. Recent development in derivative ultraviolet= visible absorption spectrophotometry. Anal. Chimica Acta 2009, 635, 22-44.
32. Novakova, L.; Satinsky, D.; Solich, P. HPLC methods for the determination of simvastatin and atorvastatin. TRAC 2008, 27, 352-367.
33. Chaudhari, B.; Patel, N.; Shah, P. Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products. Chem. Pharm. Bull. 2007, 55, 241-246. (Pubitemid 46246818)
34. Mohammadi, A.; Rezanour, N.; Ansari, M.; Bidkorbeh, F.; Hashem, M.; Walker, R. A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets. J. Chromatogr. B 2007, 846, 215-221. (Pubitemid 46149520)
35. ICH, Q2B Validation of Analytical Procedure: Methodology, in: proceeding of the International Conference on Harmonization, Geneva, March 1996.
36. ICH, Guidance on Analytical Method Validation, in: Proceedings of International Convention on Quality for the Pharmaceutical Industry, Toronto, Canada, September 2002.
37. Schmitt-Kopplin, P.; Burhenne, J.; Freitag, D.; Spiteller, M.; Kettrup, A. Development of capillary electrophoresismethods for the analysis of fluoroquinolones and application to the study of the influence of humic substances on their photodegradation in aqueous phase. J. Chromatogr. A 1999, I, 253-259.
38. Muijselaar, M.; Classens, A.; Cramers, A. Parameters controlling the elution window and retention factors in micellar electrokinetic capillary chromatography J. Chromatogr. A 1995, 696, 273-284.
39. McLaughlin, M.; Nolan, A.; Lindahl, L.; Palmieri, H.; Anderson, W.; Morris, C.; Morrison, A. Bronzert, J. Pharmaceutical drug separations by HPCE [high-performance capillary electrophoresis]; practical guidelines. J. Liq. Chromatogr. 1992, 15, 961-973.
40. Kavalírová , A.; Pospí-silová , M.; Karlíček, R. Enantiomeric purity determination of tamsulosin by capillary electrophoresis using cyclodextrins and a polyacrylamide-coated capillary. Farmaco. 2005, 60, 834-839.
41. Lanz, C.; Falmagne, J.; l'Escaille, F.; Marti, U.; Thormann, W. Determination of carbohydrate-deficient transferrin in human serum with capillary zone electrophoresis: Sample preparation strategies for the removal of interferences caused by increased levels of immunoglobulins. J. Chromatogr. A 2008, 1206, 33-40.
42. Ragno, G.; Cione, E.; Garofalo, G.; Genchi, G.; Loele, A.; Risoli, A.; Spagnpletta, A. Design and monitoring of photostability systems for amlodipine dosage forms. Int. J. Pharm. 2003, 265, 125-132.
43. Laidler, S.; Meiser, H. Physical Chemistry; 3rd Ed.; Houghton Mifflin: New York. 1999, 454.
44. Abdoh, A.; AL-Omari, M.; Badwan, A.; Jaber, Y. Amlodipine besylateexcipients interaction in solid dosage form. Pharm. Dev. Technol. 2004, 9, 15-24.
45. Jemal, M.; Ouyang, Z.; Chen, C.; Teitz, D. Quantitation of the acid and lactone forms of atorvastatin and its biotransformation products in human serum by high-performance liquid chromatography with electrospray tandem mass spectrometry. Rapid Commun. Mass Spectrom. 1999, 13, 1003-1015.