Abstract

NOVEL ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF SELECTED ANTICANCER AND ANTIVIRAL DRUG

S. Subramanyam*, Suryaprabha Matangi, Sanmati Kumari, Aman Kumar

ABSTRACT

HPLC method development and validation are critical in new drug discovery, development, and manufacturing, as well as a variety of other human and animal studies. Validation of analytical methods is required during drug development and manufacturing to ensure that these analytical methods are fit for their intended purposes. The present review represents different analytical methods and validation parameters for selected five anticancer drugs such as topotecan, paclitaxel, clofarabine, acalabrutin and 5-fluorouracil using HPLC and LC-MS/MS. To optimize the method for selected anti-cancer drugs, several chromatographic parameters were investigated, such as mobile phase selection, column selection, detector selection, and method validation parameters such as accuracy, specificity, precision, limit of detection (LOD), limit of quantitation (LOQ), ruggedness, robustness, and system suitability etc. An extensive literature survey has been done for the selected anticancer drugs based on the research articles published in various pharmaceutical and analytical chemistry journals. This assessment explains that the superiority of the HPLC and LC-MS methods reviewed is based on the quantitative analysis of drugs in formulations. This review can provide a comprehensive insight for researchers to develop an accurate reverse HPLC method and validate of novel anticancer drugs.

Keywords: Method Validation, High performance Liquid Chromatography (HPLC/LCMS), Topotecan, Paclitaxel, Clofarabine, Nilotinib and 5 Fluorouracil.