Harshkumar Brahmbhatt
Sumandeep Vidhyapeeth, India
Title: Development of rapid and sensitive spectrofluorimetry method for determination of polysorbate 80 from pharmaceutical formulation
Biography
Biography: Harshkumar Brahmbhatt
Abstract
Polysorbate 80 is a nonionic surfactant derived from polyethoxylated sorbitan. It is often used in the pharmaceutical formulation for solubility and stability of the product. An optimal concentration of polysorbate 80 is required for its effect. The methods reported for the determination of polysorbate 80 are based on HPLC separation with evaporative light scattering detection or charged aerosol detection. A simple, rapid and sensitive pectrofluorimetry method was developed for the determination of a non-ionic surfactant polyoxyethylene sorbitan monooleate (Polysorbate 80) from a pharmaceutical formulation. The proposed method is based on a fluorescence enhancement of the probe 4',5’- dibromo-2’,7’-dinitro-fluorescein disodium salt (Eosin B, 4µg/mL) in the presence of a surfactant (polysorbate 80). The fluorescence intensity was recorded using excitation wavelength (λex) at 545nm and emission wavelength (λem) at 580nm. The solutions were adjusted to pH 4.0 using a citric acid buffer. The calibration curves were obtained in the range of 16 µg/mL to 80 µg/mL of polysorbate 80 with a regression coefficient >0.99. The developed method was validated as per the ICH Q2 (R1) guideline in terms of linearity, precision, accuracy, robustness, detection limit and quantification and specificity. The limit of detection and limit of quantification for polysorbate 80 was found to be 2µg/mL and 16µg/mL, respectively. The developed method was successfully applied for the determination of polysorbate 80 in marketed ophthalmic solution and in-house prepared microemulsion containing polysorbate 80.