SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TEDIZOLID PHOSPHATE BY HYDROTROPY
Arun Singh*, Mr. Narottam Singh Kushwah, Dr. Avinash Krishnrao Kondalkar
ABSTRACT
This study focuses on the development and validation of a spectrophotometric method for the estimation of tedizolid phosphate using hydrotropy. The developed method utilizes the principle of hydrotropy, a solubilization technique, to enhance the solubility and subsequent estimation of tedizolid phosphate. Sodium benzoate was selected as the hydrotropic agent, which effectively increases the solubility of tedizolid phosphate in the aqueous medium. The solubility enhancement property of sodium benzoate enables the spectrophotometric estimation of tedizolid phosphate at a specific wavelength. Several parameters of the spectrophotometric method were optimized, including the concentration of sodium benzoate, wavelength selection, and linearity range. The method was validated according to International Conference on Harmonization (ICH) guidelines for parameters such as accuracy, precision, linearity, specificity, and robustness. The validation results confirmed the reliability and suitability of the developed method for the estimation of tedizolid phosphate. The proposed spectrophotometric method demonstrated good linearity over the concentration range of 10-50?g/mL. The developed method exhibited satisfactory accuracy, precision, and specificity. The robustness of the method was also evaluated by introducing deliberate variations in experimental conditions, and the results confirmed its robust nature. In conclusion, the developed spectrophotometric method utilizing hydrotropy for the estimation of tedizolid phosphate provides a simple, accurate, and cost-effective approach for routine analysis in pharmaceutical industries. The validated method can be utilized for the quality control and assessment of tedizolid phosphate formulations, ensuring their safety and efficacy.
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