Bioanalytical method development and validation for the simultaneous estimation of glutathione and antioxidant supplements using quality by design approach

Abstract

The research work focused on developing different eco friendly robust analytical methods by using the analytical quality by design AQbD concept and green chemistry principles for the quantification of selected antioxidants in different matrices The study has expanded its scope to assess the clinical importance by measuring the intracellular glutathione levels in SCC15 cell lines Two new environmentally friendly spectrophotometric methods for analyzing silybin and curcumin in bulk and marketed formulations were developed and validated according to ICH guidelines One novel chromatographic technique for the simultaneous quantification of glutathione silybin and curcumin was developed in bulk and marketed formulation and validated as per ICH guidelines and the method was optimized for bioanalytical study in human plasma and validated as per USFDA guidelines Antioxidants are important in cancer treatment One of the main obstacles to the successful completion of chemotherapy and radiation treatment was occurrence of side effects like oral mucositis and chemotherapy induced nephrotoxicity caused by the decrease in intracellular glutathione Utilizing antioxidants as a supplementary treatment to mitigate the negative effects of chemotherapy and radiation therapies is highly important and supports the enhancement of overall well being. Analyzing the impact of antioxidant supplements silybin and curcumin on glutathione levels in the oral squamous carcinoma cancer cell line SCC15 was done using LCMS designed to mimic the clinical scenario The supplementation of SCC 15 cell lines with silybin and curcumin increased intracellular glutathione levels post radiation when compared to the untreated newline