A study of impurity profiling via method development and force degradation in hydrocortisone butyrate at low concentration

Abstract

Abstract Background Since long, triamcinolone and fluocinolone, fluorinated derivatives, have been used for treating various types of dermatitis. Rosacea and perioral dermatitis are the most common side effects observed with prolonged use of fluorinated derivatives. Recent studies have shown that these adverse effects are more severe at low doses of fluorinated derivatives compared to low doses of non-fluorinated derivatives. Therefore, this study focused on impurity profiling through force degradation studies of hydrocortisone butyrate in a 0.1% lotion. Results A precise and robust method with low concentration was established for the estimation of hydrocortisone butyrate in bulk and formulations was done using the RP-HPLC technique. The mobile phase consisted of a combination of acetonitrile and purified water (30:70% v/v) and acetonitrile and purified water (95:5% v/v), with detection at a wavelength of 254 nm and a total run time of 20 min. The method demonstrated linearity and accuracy within the concentration range of 0.1–250 µg/mL and 50–125 µg/mL, respectively, with an r2 value of 0.999. Stress stability studies were conducted on hydrocortisone butyrate, revealing 11% degradation in alkaline conditions and 18% degradation in photolytic conditions. Conclusion The established method can be commercially used as it exhibits excellent linearity. Impurities were identified by injecting the reference standard, and their retentions were confirmed. The identified impurities included hydrocortisone, hydrocortisone-21-butyrate, hydrocortisone 3-methyl enol ether 17-butyrate, and hydrocortisone 17, 21-methylorthobutyrate, with retention times of 2.89, 9.14, 13.70, and 16.25 min, respectively. This precise method can be utilized in commercial applications for the accurate identification of hydrocortisone butyrate at low concentrations.