Environmentally Benign UV Spectrophotometric and Stability-Indicating RP-HPLC Methods for Tedizolid Determination: Method Development, Validation, Forced Degradation and Greenness Assessment

Objective: This study aims at developing and validating of three safe UV spectroscopic techniques (zero order, first derivative and area under the curve) as well as a simple and stability-indicating RP-HPLC assay for the quantitation of Tedizolid in its bulk as well as dosage form. Significance: Development of green, rapid, reliable and cost-effective methods is in great demand in pharmaceutical quality control and stability studies. The application of principles of green analytical chemistry with the optimized and validated method has yielded the facile, accurate and eco-friendly method for regular pharmaceutical analysis. Methods: Validation was successfully carried out for three UV spectrophotometric techniques using green distilled water and a fast, stable and specific RP-HPLC. Forced degradation of the target drug was performed by RP-HPLC and green analysis of all methods were performed using standard methods Analytical Eco-Scale, BAGI, MoGAPI and ACS Green Chemistry Institute Analytical Procedure Calculator (ACS-GCI). Results: The UV techniques resulted linear over 3-15 μg/mL (r=0.999), whilst the RP-HPLC technique was linear over the interval 5-25 μg/mL (R=0.997), providing RT 2.7 min. All presented acceptable levels of specificity, accuracy (99.91-100.80%), precision (%RSD <2), robustness and sensitivity. RP-HPLC clearly allowed the separation of Tedizolid from the respective impurities (in acidic, alkaline, oxidative, thermal and photolytic stress). Green evaluation presented excellent properties and values of Analytical Eco-Scale (100% for the UV and 86% for the RP-HPLC techniques). Conclusions: The proposed UV spectrophotometric and RP-HPLC methods were simple, fast, precise, validated, stabilityindicating and eco-friendly and are useful in the quality control and stability studies of Tedizolid both in bulk drug and in tablet dosage forms.