Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond
Samo za registrovane korisnike
2005
Članak u časopisu (Objavljena verzija)
Metapodaci
Prikaz svih podataka o dokumentuApstrakt
Indinavir, an antiviral drug, is a member of the novel hydroxyaminopentane amides class of HIV-1 protease inhibitors. It is the active substance in capsules which contain 400 mg indinavir as the sulfate salt and degradation products, a lactone and cis-aminoindanol, arising as a result of hydrolysis of its amide bond (at most 1.5% of the lactone and 0.5% cis-aminoindanol). RP HPLC has been evaluated as a method for qualitative and a quantitative analysis of indinavir and its degradation products in capsules. During method development the effects of several stationary and mobile phases on the separation were investigated. Separations were performed on an X Terra RP18, 150 mm x 4.6 mm, 5 mu m particle size, column at 20 degrees C. The mobile phase was 35:65 (v/v) mixture of acetonitrile and an aqueous solution of sodium lauryl sulfate and triethylamine. UV detection was performed at 214 nm. Important statistical data were determined for validation of the selectivity/specificity, linearity..., precision, robustness, limit of detection, and limit of quantitation of the method. The validated method was then used for determination of amounts of indinavir (recovery between 100.6 and, 103.1%) and compounds resulting from hydrolysis of its amide bond (the lactone, 0.265%, and cis-aminoindanol, 0.07%). The method is suitable for simultaneous determination of indinavir and its degradation products in pharmaceuticals and the bulk drug.
Ključne reči:
column liquid chromatography / response-surface methodology / validation / Indinavir / products from amide bond hydrolysisIzvor:
Chromatographia, 2005, 62, 5-6, 233-238Izdavač:
- Springer Heidelberg, Heidelberg
DOI: 10.1365/s10337-005-0617-5
ISSN: 0009-5893
WoS: 000232129200002
Scopus: 2-s2.0-24744455192
Institucija/grupa
PharmacyTY - JOUR AU - Jančić, Biljana AU - Medenica, Mirjana AU - Ivanović, D AU - Malenović, Anđelija PY - 2005 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/617 AB - Indinavir, an antiviral drug, is a member of the novel hydroxyaminopentane amides class of HIV-1 protease inhibitors. It is the active substance in capsules which contain 400 mg indinavir as the sulfate salt and degradation products, a lactone and cis-aminoindanol, arising as a result of hydrolysis of its amide bond (at most 1.5% of the lactone and 0.5% cis-aminoindanol). RP HPLC has been evaluated as a method for qualitative and a quantitative analysis of indinavir and its degradation products in capsules. During method development the effects of several stationary and mobile phases on the separation were investigated. Separations were performed on an X Terra RP18, 150 mm x 4.6 mm, 5 mu m particle size, column at 20 degrees C. The mobile phase was 35:65 (v/v) mixture of acetonitrile and an aqueous solution of sodium lauryl sulfate and triethylamine. UV detection was performed at 214 nm. Important statistical data were determined for validation of the selectivity/specificity, linearity, precision, robustness, limit of detection, and limit of quantitation of the method. The validated method was then used for determination of amounts of indinavir (recovery between 100.6 and, 103.1%) and compounds resulting from hydrolysis of its amide bond (the lactone, 0.265%, and cis-aminoindanol, 0.07%). The method is suitable for simultaneous determination of indinavir and its degradation products in pharmaceuticals and the bulk drug. PB - Springer Heidelberg, Heidelberg T2 - Chromatographia T1 - Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond VL - 62 IS - 5-6 SP - 233 EP - 238 DO - 10.1365/s10337-005-0617-5 ER -
@article{ author = "Jančić, Biljana and Medenica, Mirjana and Ivanović, D and Malenović, Anđelija", year = "2005", abstract = "Indinavir, an antiviral drug, is a member of the novel hydroxyaminopentane amides class of HIV-1 protease inhibitors. It is the active substance in capsules which contain 400 mg indinavir as the sulfate salt and degradation products, a lactone and cis-aminoindanol, arising as a result of hydrolysis of its amide bond (at most 1.5% of the lactone and 0.5% cis-aminoindanol). RP HPLC has been evaluated as a method for qualitative and a quantitative analysis of indinavir and its degradation products in capsules. During method development the effects of several stationary and mobile phases on the separation were investigated. Separations were performed on an X Terra RP18, 150 mm x 4.6 mm, 5 mu m particle size, column at 20 degrees C. The mobile phase was 35:65 (v/v) mixture of acetonitrile and an aqueous solution of sodium lauryl sulfate and triethylamine. UV detection was performed at 214 nm. Important statistical data were determined for validation of the selectivity/specificity, linearity, precision, robustness, limit of detection, and limit of quantitation of the method. The validated method was then used for determination of amounts of indinavir (recovery between 100.6 and, 103.1%) and compounds resulting from hydrolysis of its amide bond (the lactone, 0.265%, and cis-aminoindanol, 0.07%). The method is suitable for simultaneous determination of indinavir and its degradation products in pharmaceuticals and the bulk drug.", publisher = "Springer Heidelberg, Heidelberg", journal = "Chromatographia", title = "Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond", volume = "62", number = "5-6", pages = "233-238", doi = "10.1365/s10337-005-0617-5" }
Jančić, B., Medenica, M., Ivanović, D.,& Malenović, A.. (2005). Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond. in Chromatographia Springer Heidelberg, Heidelberg., 62(5-6), 233-238. https://doi.org/10.1365/s10337-005-0617-5
Jančić B, Medenica M, Ivanović D, Malenović A. Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond. in Chromatographia. 2005;62(5-6):233-238. doi:10.1365/s10337-005-0617-5 .
Jančić, Biljana, Medenica, Mirjana, Ivanović, D, Malenović, Anđelija, "Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond" in Chromatographia, 62, no. 5-6 (2005):233-238, https://doi.org/10.1365/s10337-005-0617-5 . .