Shalini Gupta
King George’s Medical University, India
Title: Development and validation of HPLC method for the determination of 5-fluorouracil as intra oral nanogel for oral cancer treatment
Biography
Biography: Shalini Gupta
Abstract
This study focuses on development and validation of the HPLC method for the determination of 5-Fluorouracil (5 FU), used in chemotherapy for oral cancer treatment as intra oral nanogel formulation. Oral squamous cell carcinoma (OSCC) is sixth most common cancer and mostly occurs in middle and older ages. The HPLC method was validated according to the International Conference on Harmonization (ICH) guide¬lines (2005). The following characteristics were consid¬ered for validation: specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness. A fast, simple and reliable HPLC method using photodiode array detection for determining the encapsu¬lation efficiency of 5-FU in PLA and PLA-PEG blended nanoparticles has been developed and validated according to the ICH guidelines. The method fulfilled the require¬ments to be considered as a reliable and feasible method, including specificity, linearity, precision, accuracy, robustness, LOD and LOQ and further be evaluated in nanogel fomulation. The analytical procedure has a chromatographic run time of 4.30 min, which allows analyzing a large number of samples in a short period of time.