European Journal of Biomedical and Pharmaceutical Sciences

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF SELECTED ANTINEOPLASTIC DRUG TREOSULFAN BY USING DIFFERENT ANALYTICAL TECHNIQUES

Dr. Santhosh Illendula*, Kurumeti Divya, Mothe Praneeth, Vusala Tejaswi, Varipally Sai Sindhu, Vootkuri Nihathi, Jetamoni Mahesh, Dr. Suthakaran Raj

ABSTRACT

Tresosulfan a synthetic alkylating agent and bifunctional prodrug that undergoes pH dependent conversion to active epoxybutane derivatives responsible for its cytotoxic activity. It is used mainly as a myeloablative agent in conditioning regimens prior to hematopoietic stem-cell transplantation and has also been investigated in the treatment of various malignancies. Owing to its therapeutic importance and the need for accurate drug quantification, development of a simple, rapid, sensitive, and reliable analytical method for the estimation of Treosulfan is essential. The present study is focused on the development and validation of an analytical method for the estimation of Treosulfan using Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC). Method development involves optimization of chromatographic parameters such as stationary phase, mobile phase composition, flow rate, injection volume, detection wavelength, column temperature, and run time to obtain satisfactory separation and symmetrical peak shape with good resolution. The developed method is intended to provide adequate sensitivity and reproducibility for the quantitative determination of Treosulfan in pharmaceutical formulations. The developed analytical method is validated according to ICH guidelines, with respect to parameters including specificity, linearity, accuracy, precision, range, limit of detection (LOD), limit of quantification (LOQ), robustness, and system suitability. The method is expected to demonstrate good linearity over the selected concentration range, satisfactory accuracy and precision, low LOD and LOQ, and robustness against small deliberate changes in chromatographic conditions.

Keywords: Method development, method validation, RP-HPLC, Pharmaceutical analysis, chromatography method, ICH guidelines, Quality control.