A novel reverse phase high-performance liquid chromatography (RP-HPLC–UV) method for the estimation of alosetron HCl and its validation

• Autorzy: Karthik Y. , Babu B. , Meyyanathan S. , Awari V. , Krishnaveni N.
• Języki publikacji: EN

Abstrakty

EN

A novel simple, sensitive, and rapid isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed for the quantitative determination of alosetron HCl, a 5-HT3 antagonist used in the treatment of severe irritable bowel syndrome (IBS) in females. The optimized chromatographic separation was achieved using a stationary phase of Phenomenex® kromasil C-18 (250 mm × 4.6 mm; 5 μm particle size) column, and mobile phase of 0.025 M disodium hydrogen orthophosphate buffer, pH adjusted to 3.0 with orthophosphoric acid, and acetonitrile in the ratio of 65:35 (v/v) with a flow rate of 1 mL min. ^-1 The UV detection was carried out at 217 nm. The developed method provided linear responses within the concentration range 100–2000 ng Ml ^-1, and regression analysis showed a correlation coefficient value (r2) of 0.997. The HPLC method was validated as per International Conference on Harmonization (ICH) guidelines with respect to selectivity, precision, linearity, and robustness. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 1 ng Ml ^-1 and 5 ng Ml ^-1, respectively.

Słowa kluczowe

EN

alosetron; RP-HPLC; validation

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2015
• Tom: Vol. 27, no. 2
• Strony: 321--330
• Opis fizyczny: Bibliogr. 7 poz., rys., tab.

Twórcy

autor

Karthik Y.

• JSS College of Pharmacy Department of Pharmaceutical Analysis Udhagamandalam, The Nilgiris Tamilnadu 643001 India

autor

Babu B.

• JSS College of Pharmacy Department of Pharmaceutical Analysis Udhagamandalam, The Nilgiris Tamilnadu 643001 India

autor

Meyyanathan S.

• JSS College of Pharmacy Department of Pharmaceutical Analysis Udhagamandalam, The Nilgiris Tamilnadu 643001 India

autor

Awari V.

• JSS College of Pharmacy Department of Pharmaceutical Analysis Udhagamandalam, The Nilgiris Tamilnadu 643001 India

autor

Krishnaveni N.

Bibliografia

• [1] D.A. Drossman, M. Camilleri, E.A. Mayer, and W.E. Whitehead, Gastroenterology, 123, 2108–2131 (2002)
• [2] http://www.rxlist.com/lotronex-drug.htm (accessed on 15.07.2012)
• [3] http://www.drugs.com/mmx/alosetron.html (accessed on 17.07.2012)
• [4] http://www.usp.org/usp-nf/development-process/priority-new-monographs (accessed on 01.07.2012)
• [5] Thomas L. Lloyd, Samir K. Gupta, Ann E. Gooding, and John R. Alianti, J. Chromatogr. B, 678, 261–267 (1996)
• [6] S.A. Wring, R.M. O'Neill, J.L. Williams, H.L. Birch, C.P. Goddard, P.D. Andrew, and W.N. Jenner, Analyst, 119 (11), 2395–2401 (1994)
• [7] ICH-Q2B Validation of Analytical Procedures: Methodology International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, 1996