Bioanalytical method development and validation of bleomycin sulphate
Keywords:
Bleomycin, anti – neoplastic, validation, HPLC, linearity, accuracyAbstract
Bleomycin is an anti-neoplastic drug that has recently been used for the treatment of vascular anomalies. An expedient method was developed for the determination of plasma bleomycin levels using ion-paired reversed phase high performance liquid chromatography (HPLC). The concentration was found to be proportional to the area and the response of the detector was determined to be linear over the range of 1-6 µg/ml for both Bleomycin A1 and Bleomycin B2. Recovery was approximately 100%. This method provides a simple and rapid way of determining the levels of bleomycin A2 and B2 in human and rat plasma
Downloads
References
Pharne AB, Santhakumari B, Ghemud AS, Jain HK, Kulkarni MJ. Bioanalytical Method Development and Validation of Vildagliptin a Novel Dipeptidyl Peptidase Iv Inhibitor By RP-HPLC Method. International Journal of Pharmacy and Pharmaceutical Sciences, 4, 1–5 (2012).
Kirthi A, Shanmugam R, Prathyusha SM, Basha J. A review on bioanalytical method development and validation by RP-HPLC. Journal of Global Trends in Pharmaceutical Sciences, 5, 2265–71 (2014).
Abraham AT, Lin J, Newton DL, Rybak S, Hecht SM. RNA cleavage and inhibition of protein synthesis by bleomycin. Chemical & Biology, 10, 45–52 (2003).
Blanchet B, Saboureau C, Benichou AS, Billemont B, Taieb F, Ropert S, Dauphin A, Goldwasser F, Tod M. Development and validation of an HPLC-UV-visible method for sunitinib quantification in human plasma. Clinica Chimica Acta, 404, 134–9 (2009).
Burger RM, Peisach J, Horwitz SB. Activated bleomycin. A transient complex of drug, iron, and oxygen that degrades DNA. Journal of Biological Chemistry, 256, 11636–44 (1981).
Carter BJ, de Vroom E, Long EC, van der Marel G a, van Boom JH, Hecht SM. Site-specific cleavage of RNA by Fe(II).bleomycin. Proceedings of the National Academy of Sciences of the United States of America, 87, 9373–7 (1990).
Chan CC, Leo YC, Lam H. Analytical method validation and Instrument Perfomance Validation.Vol-I, Wiley Interscince, USA.2004
Chan ECY, Wee PY, Ho PC. The value of analytical assays that are stability-indicating. Clinica Chimica Acta, 288, 47–53 (1999).
Chen J, Stubbe J. Bleomycins: New methods will allow reinvestigation of old issues. Current Opinion in Chemical Biology, 8, 175–81 (2004).
Chitturi SR, Bharathi C, Reddy AVR, Reddy KC, Sharma HK, Handa VK, Dandala R, Bindu VH. Impurity profile study of lopinavir and validation of HPLC method for the determination of related substances in lopinavir drug substance. Journal of Pharmaceutical and Biomedical Analysis, 48, 1430–40 (2008).
Chmielewska A, Konieczna L, Plenis A, Lamparczyk H. Quantitative Determination of Pentoxifylline in Human Plasma. Acta Chromatographica, 16, 70–9 (2006).
Collier JW, Shah RB, Bryant AR, Habib MJ, Khan MA, Faustino PJ. Development and application of a validated HPLC method for the analysis of dissolution samples of levothyroxine sodium drug products. Journal of Pharmaceutical and Biomedical Analysis, 54, 433–8 (2011).
Sridharan D, Thenmozhi A, Sundaranandavalli S. Article Article Bioanalytical Method Development and Validation of Atenolol in Human Plasma By Lc Ms. Asian Journal of Pharmaceutical and Clinical Research, 3, 92–4 (2010).
Published
How to Cite
Issue
Section
Copyright (c) 2020 Yash Prashar, Harkaran Singh Rana, Souravh Bais
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
