HPLC Method for Monitoring of Degradation Products in Picoplatin Stability Study
- 147 Downloads
An analytical method combining high-performance liquid chromatography (HPLC) with UV detection was developed for an easy and rapid assay determination of the anticancer drug picoplatin (=cis-[Pt(NH3)(2-methylpyridine)Cl2]) and its degradation products. An ion exchanger was used as the stationary phase with an aqueous solution of NaH2PO4 with pH adjusted to 3.0 with H3PO4 as the mobile phase. The calibration curve was linear within the concentration range of 0.10–0.50 g L−1 (R 2 ≥ 0.998). The limit of detection was 0.05 g L−1 and limit of quantification was 0.09 g L−1. The developed method was characterized with a high precision (≤6.0%, determined as RSD), an acceptable accuracy (the values of recovery were from intervals 98–103%). The developed method was used for assessing the stability of picoplatin during a stability study.
KeywordsColumn liquid chromatography Stress stability study Anticancer drug Picoplatin
We acknowledge the financial support of the Grant Agency of the Czech Republic (Grant GA CR 203/08/H032), Ministry of Education, Youth and Sports of the Czech Republic (Grant No. MSM 6046137301 and research program 2B08021), and of the Ministry of Industry and Trade of the Czech Republic (Grant No. MPO 2A-2TP1/049).
- 1.http://epp.eurostat.ec.europa.eu, download 18. 2. 2010
- 3.Barnard CF (Johnson Matthey Public Limited Company): WO 2009/150448 A1Google Scholar
- 4.Wong ESY, Giandomenico CM (Anormed Inc.): WO 01/76569 A2Google Scholar
- 5.Wong ESY, Giandomenico CM (Anormed Inc.): WO 00/61590 A1Google Scholar
- 7.Kelland LR (1999) The development of orally active platinum drugs. In: Lippert B (ed) Cisplatin. Verlag Helvetica Chimica Acta, Zürich, pp 498–521Google Scholar
- 9.ICH (2005) Stability testing guidelines: stability testing of new drug substances and products Q1A. International Conference on Harmonization, IFPMA, GenevaGoogle Scholar
- 10.ICH (2005) Photostability testing of new active substances and medicinal products Q1B. International Conference on Harmonization, IFPMA, GenevaGoogle Scholar
- 13.Potucká L, Housková J, Hamtil R, Kačer P, Červený L (2010) Anal Lett (in press)Google Scholar
- 14.Meloun M, Militky J (2004) Statisticke zpracovani experimentalnich dat, 2nd edn. ACADEMIA Prague, Czech RepublicGoogle Scholar