Validated RP-HPLC analysis of irinotecan HCl in the bulk material and in pharmaceutical formulations

Czasopismo : Acta Chromatographica
Tytuł artykułu : Validated RP-HPLC analysis of irinotecan HCl in the bulk material and in pharmaceutical formulations

Autorzy :
Turło, J.
Medical University of Warsaw Department of Drug Technology 1 Banacha Street 02-097 Warsaw Poland Medical University of Warsaw Faculty of Pharmacy 1 Banacha Street 02-097 Warsaw Poland, jadwiga.turlo@wum.edu.p,
Komsta, Ł.
Medical University of Lublin Chair and Department of Medicinal Chemistry, Faculty of Pharmacy Jaczewskiego 4 20-090 Lublin Poland Medical University of Lublin Chair and Department of Pharmaceutical Botany, Faculty of Pharmacy Chodźki 1 20-093 Lublin Pola, lukasz.komsta@am.lublin.pl,
Vasta, J. D.
Lafayette College Department of Chemistry Easton PA 18042-1782 USA Lafayette College Department of Biology Easton PA 18042-1782 USA, shermaj@mail.lafayette.edu,
Sajewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland, kowalska@us.edu.pl,
Raju, Ch. B. V. N.
Aurobindo Pharma Limited Srikakulam Dist. Pydibhimavaram 532 409 India Andhra University Department of Inorganic and Analytical Chemistry Visakhapatnam 530 003 India, chbvn_5@yahoo.co.in,
Shende, P.
NMIMS University School of Pharmacy and Technology Management V.L. Mehta Road, Vile Parle (W) Mumbai 400056 India, shendepravin94@yahoo.co.in,
Abstrakty : An isocratic reversed-phase high-performance liquid chromatographic (RPHPLC) method for analysis of irinotecan HCl has been developed and validated. Separation was achieved on a C 18 column with potassium dihydrogen phosphate buffer (pH adjusted to 3.5 with orthophosphoric acid)-acetonitrile-methanol 55:25:20 ( v/v ) as mobile phase at a flow rate of 1.0 mL min-1. UV detection was performed at 254 nm. The method is simple, sensitive, rapid, and selective, and linear over the range 30-70 µg mL-1for assay of irinotecan HCl. The precision of the assay method was below 1.0% RSD. Mean recovery was in the range 98.0-102.0%. Recovery of the active pharmaceutical ingredient from dosage forms ranged from 99.0 to 101.0. The method is useful for quality control in bulk manufacture and of the pharmaceutical formulation.

Słowa kluczowe : irinotecan HCl, RP-HPLC analysis, method validation,
Wydawnictwo : University of Silesia in Katowice
Rocznik : 2009
Numer : Vol. 21, no. 1
Strony : 71 – 82
Bibliografia : 1 S. Sawada, S. Okajima, R. Aiyama, K. Nokota, T. Furuta, T. Yokokura, E. Sugini, K. Yamaguchi, and K. Miyasaka, Chem. Pharm. Bull., 39 , 1446 (1991)
2 Y. Kawato, M. Aonuma, Y. Hirota, H. Kuga, and K. Sato, Cancer Res., 51 , 4187 (1991)
3 G. Nishimura, T. Satou, Y. Yoshimitsu, Y. Kurosaka, and T. Fujimura, Jpn. J. Cancer Chemother., 22 , 93 (1995)
4 Y. Ohe, Y. Sasaki, T. Shinkai, K. Eguchi, T. Tamura, A. Kojima, H. Kunikane, H. Okamoto, A. Karato, H. Ohmatsu, F. Kanzawa, and N. Saijo, J. Natl. Cancer Inst. 84 , 972 (2004)
5 K. Takasago, Y. Kasai, Y. Kitano, K. Mori, K. Kakihata, M. Hirohashi, and M. Nonura, Folia Pharmacol. Jpn., 105 , 447 (1995)
6 A. Kono and Y. Hara, Jpn. J. Cancer Chemother., 18 , 2175 (1991)
7 R. Mick, E. Gupta, E Vokes, and M. Ratain, J. Clin. Oncol., 14 , 2012 (1996)
8 H. Sumoyoshi, Y. Fujiwara, T. Ohune, N. Yamaoka, K. Tamura, and M. Yamakido, J. Chromatogr. B, 670 , 309 (1995)
9 A. Sparreboom, P. Bruijn, M. Jonge, W. Loos, J. Stoter, J. Verweij, and K. Nooter, J. Chromatogr. B, 712 , 225 (1998)
10 J. Escoriaza, A. Aldaz, C. Castellanos, E. Calvo, and J. Giraldez, J. Chromatogr. B, 740 , 159 (2000)
11 M. Palumbo, C. Sissi, B. Gatto, S. Moro, and G. Zagotto, J. Chromatogr. B, 764 , 121 (2001).
DOI :
Cytuj : Turło, J. ,Komsta, Ł. ,Vasta, J. D. ,Sajewicz, M. ,Raju, Ch. B. V. N. ,Shende, P. , Validated RP-HPLC analysis of irinotecan HCl in the bulk material and in pharmaceutical formulations. Acta Chromatographica Vol. 21, no. 1/2009
facebook