Journal : Acta Chromatographica
Article : Validated RP-HPLC analysis of irinotecan HCl in the bulk material and in pharmaceutical formulations

Authors :
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,
Abstract : 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.

Keywords : irinotecan HCl, RP-HPLC analysis, method validation,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 1
Page : 71 – 82

Bibliography
: 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 :
Qute : Turło, J. ,Komsta, Ł. ,Vasta, J. D. ,Sajewicz, M. ,Raju, Ch. B. V. N. ,Shende, P. ,Shende, P. , Validated RP-HPLC analysis of irinotecan HCl in the bulk material and in pharmaceutical formulations. Acta Chromatographica Vol. 21, no. 1/2009
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