77
Views
6
CrossRef citations to date
0
Altmetric
Pharmaceutical Analysis

A Chemometrical Approach to Optimization and Validation of an HPLC Assay for Rizatriptan and its Impurities in Tablets

, , &
Pages 2301-2316 | Received 29 Apr 2007, Accepted 15 Jun 2007, Published online: 25 Oct 2007

References

  • Ahuja , S. 1998 . Impurities Evaluation of Pharmaceuticals New York : Marcel Dekker, Inc. .
  • Altinoz , S. , Ucar , G. and Yıldız , E. 2002 . Determination of rizatriptan in its tablet dosage forms by UV spectrophotometric and spectrofluorimetric methods . Anal. Lett. , 35 : 2471 – 2485 .
  • Araujo , P. 2000 . A new high performance liquid chromatography multifactor methodology for systematic and simultaneous optimization of the gradient solvent system and the instrumental/experimental variables . Trends Anal. Chem. , 19 : 524 – 529 .
  • Barrish , A. , Olah , T. V. , Gatto , G. J. , Dobrinska , M. R. and Gilbert , J. D. 1996 . The use of stable isotope labeling and liquid chromatography/tandem mass spectrometry techniques to study the pharmacokinetics and bioavailability of the antimigraine drug, MK‐0462 in dogs . Rapid Commun. Mass Spectrom. , 10 : 1033 – 1037 .
  • Chen , J. , Glancy , K. , Chen , X. and Alasandro , M. 2001 . Investigation of pharmaceutical high‐performance liquid chromatography assay bias using experimental design . J. Chromatogr. A , 917 : 63 – 73 .
  • Chen , J. , Jiang , X. G. , Jiang , W. M. , Mei , N. , Gao , X. L. and Zhang , Q. 2004 . Liquid chromatographic method for the determination of rizatriptan in human plasma . J. Chromatogr. B , 805 : 169 – 173 .
  • Chen , J. , Jiang , X. G. , Jiang , W. M. , Gao , X. L. and Mei , N. 2005 . Intranasal absorption of rizatriptan—in vivo pharmacokinetics and bioavailability study in humans . Pharmazie , 60 : 39 – 41 .
  • Ficarra , R. , Calabro , M. L. , Cutroneo , P. , Tommasini , S. , Melardi , S. , Semreen , M. , Furlanetto , S. , Ficarra , P. and Altavilla , G. 2000 . Validation of a LC method for the analysis of oxaliplatin in a pharmaceutical formulation using an experimental design . J. Pharm. Biomed. Anal. , 29 : 1097 – 1103 .
  • Ficarra , R. , Ficarra , P. , Tommasini , S. , Melardi , S. , Calabro , M. L. , Furlanetto , S. and Semreen , M. 2000 . Validation of a LC method for the analysis of zafirlukast in a pharmaceutical formulation . J. Pharm. Biomed. Anal. , 23 : 169 – 174 .
  • Gennaro , M. C. , Marengo , E. , Gianotti , V. and Angioi , S. 2002 . Simultaneous reversed‐phase high‐performance liquid chromatographic separation of mono‐, di‐ and trichloroanilines through a gradient elution optimized by experimental design . J. Chromatogr. A , 945 : 287 – 292 .
  • Gori , S. , Morelli , N. , Bellini , G. , Bonanni , E. , Manca , L. , Orlandi , G. , Iudice , A. and Murri , L. 2005 . Rizatriptan does not change cerebral blood flow velocity during migraine attacks . Brain Res. Bull. , 65 : 297 – 300 .
  • Hund , E. , Vander , Y. , Heyden , M. H. , Massart , D. L. and Smeyers‐Verbeke , J. 2000 . Robustness testing of a reversed‐phase high‐performance liquid chromatographic assay: comparison of fractional and asymmetrical factorial designs . J. Chromatogr. A , 874 : 167 – 185 .
  • ICH Q3A(R) . 2000 . Draft revised guidance on impurities in new drug substances . Fed. Regist , 65 : 45085 – 45090 .
  • ICH Q3B(R) . 2000 . Draft revised guidance on impurities in new drug products . Fed. Regist , 65 : 44791 – 44797 .
  • Jančić , B. , Medenica , M. , Ivanović , D. , Malenović , A. and Marković , S. 2005 . Microemulsion liquid chromatographic method for characterization of fosinopril sodium and fosinoprilat separation with chemometrical support . Anal. Bioanal. Chem. , 383 : 687 – 694 .
  • Lee , Y. , Conroy , J. A. , Stepanavage , M. E. , Mandel , C. M. , Somers , G. , McLoughlin , D. A. , Olah , T. V. , De Smet , M. and Rogers , J. D. 1999 . Pharmacokinetics and tolerability of oral rizatriptan in healthy male and female volunteers . J. Clin. Pharmacol. , 47 : 373 – 378 .
  • Lundstedt , T. , Seifert , E. , Abramo , L. , Thelin , B. , Nystrom , A. , Pettersen , J. and Bergman , R. 1998 . Experimental design and optimization . Chemom. Intell. Lab. Syst. , 42 : 3 – 40 .
  • Mahuzie , P. , Clark , B. J. , Crumpton , A. J. and Altria , K. D. 2001 . Quantitative microemulsion electrokinetic capillary chromatography analysis of formulated drug products . J. Sep. Sci. , 24 : 784 – 788 .
  • McLoughlin , D. A. , Olah , T. V. , Ellis , J. D. , Gilbert , J. D. and Halpin , R. A. 1996 . Quantitation of the 5HT1D agonists MK‐462 and sumatriptan in plasma by liquid chromatography—atmospheric pressure chemical ionization mass spectrometry . J Chromatogr. A , 726 : 115 – 124 .
  • Musson , D. G. , Birk , K. L. , Panebianco , D. L. , Gagliano , K. D. , Rogers , J. D. and Goldberg , M. R. 2001 . Pharmacokinetics of rizatriptan in healthy elderly subjects . Int. J. Clin. Pharmacol. Ther. , 39 : 447 – 452 .
  • Nowak , M. and Seubert , A. 1999 . Application of experimental design for the characterisation of a novel elution system for high‐capacity anion chromatography with suppressed conductivity detection . J. Chromatogr. A , 855 : 91 – 109 .
  • Oldman , A. D. , Smith , L. A. , McQuay , H. S. and Moore , R. A. 2002 . Pharmacological treatments for acute migraine: quantitative systematic review . Pain , 97 : 247 – 257 .
  • Orwa , J. A. , Vandenbempt , K. , Depuydt , S. , Roets , E. and Hoogmartens , J. 1999 . Liquid chromatography method for separation of clindamycin from related substances . J. Pharm. Biomed. Anal. , 20 : 745 – 752 .
  • Ragonese , R. , Mulholland , M. and Kalman , J. 2000 . Full and fractionated experimental designs for robustness testing in the high‐performance liquid chromatographic analysis of codeine phosphate, pseudoephedrine hydrochloride and chlorpheniramine maleate in a pharmaceutical preparation . J. Chromatogr. A , 870 : 45 – 51 .
  • Rao , B. M. , Sangaraju , S. , Srinivasu , M. K. , Madhavan , P. , Devi , M. L. and Kumar , P. R. 2006 . Development and validation of a specific stability indicating high performance liquid chromatographic method for rizatriptan benzoate . J. Pharm. Biomed. Anal. , 41 : 1146 – 1151 .
  • Vander Heyden , Y. , Nijhuis , A. , Smeyers‐Verbeke , J. , Vandeginste , B. G.M. and Massart , D. L. 2001 . Guidance for robustness: ruggedness tests in method validation . J. Pharm. Biomed. Anal. , 24 : 723 – 753 .
  • Vincent , A. , Lisa , W. and Pascal , T. 1998 . The reversed‐phase liquid chromatographic behavior of the new 5‐HT1D receptor agonist rizatriptan benzoate and its potential process impurities . J. Liq. Chromatogr. Related Technol. , 21 : 1649 – 1670 .
  • Vishwanathan , K. , Bartlett , M. G. and Stewart , J. T. 2000 . Determination of antimigraine compounds rizatriptan, zolmitriptan, naratriptan and sumatriptan in human serum by liquid chromatography/electrospray tandem mass spectrometry . Rapid Commun. Mass Spectrom. , 14 : 168 – 172 .
  • Williamson , D. J. , Shepheard , S. L. , Hill , R. G. and Hargreaves , R. J. 1997 . The novel anti‐migraine agent rizatriptan inhibits neurogenic dural vasodilatation and extravasation . Eur. J. Pharmacol. , 328 : 61 – 64 .
  • Ye , C. , Liu , J. , Ren , F. and Okafo , N. 2000 . Design of experiment and data analysis by JMP® (SAS institute) in analytical method validation . J. Pharm. Biomed. Anal. , 23 : 581 – 589 .
  • Zeaiter , M. , Roger , J. M. , Bellon‐Maurel , V. and Rutledge , D. N. 2004 . Robustness of models developed by multivariate calibration. Part I: The assessment of robustness . Trends Anal. Chem. , 23 : 157 – 170 .

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.