development and validation of stability indicating lc method for 10-hydroxycamptothecin发展和稳定指示lc 10-hydroxycamptothecin方法的验证.pdfVIP

American Journal of Analytical Chemistry , 2012, 3, 470-477 /10.4236/ajac.2012.37062 Published Online July 2012 (http://www.SciRP.org/journal/ajac) Development and Validation of Stability Indicating LC Method for 10-Hydroxycamptothecin 1,2* 1 2 Arala Venkateshwarlu , A. V. Rama Rao , Khagga Mukkanti 1Analytical Development Laboratory, Avra Laboratories Private Limited, Hyderabad, India 2Institute of Science Technology, Jawaharlal Nehru Technological University, Hyderabad, India * Email: Venkateshwarlu@ Received April 15, 2012; revised May 21, 2012; accepted June 2, 2012 ABSTRACT The present method gives a detailed description for the development and validation of a simple stability indicating re- verse phase liquid chromatographic method for 10-hydroxycamptothecin(10-HCTN) in the presence of its impurities namely Imp A and Imp B along with degradation products generated from forced degradation studies. The drug was subjected to stress conditions of hydrolysis (acid, base and neutral), oxidative, photolytic and thermal stress degradation. Degradation was observed when subjected to treatment with peroxides or under conditions normally used for typical acid and base hydrolysis. The drug was found to be stable under other stress conditions attempted such as photolytic and thermal. Successful separation and isolation of the drug from related impurities and degradation products formed under stress conditions was achieved on an Inertsil ODS-3V (250 mm × 4.6 mm, 5 µm) column using a phosphate buf- fer, acetonitrile, methanol and Nanopure water. The developed HPLC method was validated with respe