Novel Stability‐Indicating RP‐LC Method for the Determination of Nelfinavir Mesylate and its Related Impurities in Drug Substance and Pharmaceutical Formulations

References

• Yamada , H. , Kotaki , H. , Nakamura , T. and Iwamoto , A. 2001 . Simultaneous determination of the HIV protease inhibitors indinavir, amprenavir, saquinavir, ritonavir, and nelfinavir in human plasma by high‐performance liquid chromatography . J. Chromatogr. B , 755 : 85 – 89 .
   PubMed Web of Science ®Google Scholar
• Marzolini , C. , Telenti , A. , Buclin , T. and Biollaz , J. 2000 . Simultaneous determination of the HIV protease inhibitors indinavir, amprenavir, saquinavir, ritonavir, nelfinavir, and the non‐nucleoside reverse transcriptase inhibitor efavirenz by high‐performance liquid chromatography after solid‐phase extraction . J. Chromatogr. B , 740 : 43 – 58 .
   PubMed Web of Science ®Google Scholar
• Turner , M. L. , Reed‐Walker , K. , King , J. R. and Acosta , E. P. 2003 . Simultaneous determination of nine antiretroviral compounds in human plasma using liquid chromatography . J. Chromatogr. B , 784 : 331 – 341 .
   PubMed Web of Science ®Google Scholar
• Dailly , E. , Thomas , L. , Kergueris , M. F. , Jolliet , P. and Bourin , M. 2001 . High‐performance liquid chromatographic assay to determine the plasma levels of HIV‐protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, and saquinavir) and the non‐nucleoside reverse transcriptase inhibitor (nevirapine) after liquid–liquid extraction . J. Chromatogr. B , 758 : 129 – 135 .
   PubMed Web of Science ®Google Scholar
• Sarasa‐Nacenta , M. , Lopez‐Pua , Y. , Mallolas , J. and Blanco , J. L. 2001 . Simultaneous determination of the HIV‐protease inhibitors indinavir, amprenavir, ritonavir, saquinavir, and nelfinavir in human plasma by reversed‐phase high‐performance liquid chromatography . J. Chromatogr. B , 757 : 325 – 332 .
   PubMed Web of Science ®Google Scholar
• Justesen , U. S. , Pedersen , C. and Klitgaard , N. A. 2003 . Simultaneous quantitative determination of the HIV protease inhibitors indinavir, amprenavir, ritonavir, lopinavir, saquinavir, nelfinavir, and the nelfinavir active metabolite M8 in plasma by liquid chromatography . J. Chromatogr. B , 783 : 491 – 500 .
   PubMed Web of Science ®Google Scholar
• Janoly , A. , Bleyzac , N. , Favetta , P. and Gagneu , M. C. 2002 . Simple and rapid high‐performance liquid chromatographic method for nelfinavir, M8 nelfinavir metabolite, ritonavir, and saquinavir assay in plasma . J. Chromatogr. B , 780 : 155 – 160 .
   Google Scholar
• Chi , J. , Jayewardene , A. L. , Stone , J. A. and Motoya , T. 2002 . Simultaneous determination of five HIV protease inhibitors nelfinavir, indinavir, ritonavir, saquinavir, and amprenavir in human plasma by LC/MS/MS . J. Pharm. Biomed. Anal , 30 : 675 – 684 .
   PubMed Web of Science ®Google Scholar
• Rentsch , K. M. 2003 . Sensitive and specific determination of eight antiretroviral agents in plasma by high‐performance liquid chromatography–mass spectrometry . J. Chromatogr. B , 788 : 339 – 350 .
   PubMed Web of Science ®Google Scholar
• Van Heeswijk , R. P.G. , Hoetelmans , R. M.W. , Harms , R. and Meenhorst , P. L. 1998 . Simultaneous quantitative determination of the HIV protease inhibitors amprenavir, indinavir, nelfinavir, ritonavir, and saquinavir in human plasma by ion‐pair high‐performance liquid chromatography with ultraviolet detection . J. Chromatogr. B , 719 : 159 – 168 .
   PubMed Web of Science ®Google Scholar
• Kaul , N. , Agrawal , H. , Paradkar , A. R. and Mahadik , K. R. 2004 . Stability indicating high‐performance thin‐layer chromatographic determination of nelfinavir mesylate as bulk drug and in pharmaceutical dosage form . Anal. Chim. Acta , 502 : 31 – 38 .
   Google Scholar
• Jing , Q. , Shen , Y. , Tang , Y. , Ren , F. , Yu , X. and Hou , Z. 2006 . Determination of nelfinavir mesylate as bulk drug and in pharmaceutical dosage form by stability indicating HPLC . J. Pharm. Biomed. Anal. , 41 : 1065 – 1069 .
   PubMed Web of Science ®Google Scholar
• ICH International conference on harmonization of technical requirements for registration of pharmaceuticals for human use . “Impurities in new drug substances” , Q3A(R1)
   Google Scholar
• Inaba , T. , Birchler , A. G. , Yamada , Y. , Sagava , S. , Yokota , K. , Ando , K. and Uchida , I. 1998 . A practical synthesis of nelfinavir, an HIV protease Inhibitor, using a Noval Chiral C4 building block: (5R,6S)‐2,2‐Dimethyl‐5‐hydroxy‐1,3‐dioxepan‐6‐yl ammonium acetate . J. Org. Chem. , 63 : 7582 – 7583 .
   Web of Science ®Google Scholar
• ICH International conference on harmonization of technical requirements for registration of pharmaceuticals for human use . “Validation of analytical procedures” , Q2(R1)
   Google Scholar