Stability Indicating RP-HPLC Method for Quantification of Sarecycline and Its Impurities in Sarecycline Solid Dosage Form

The primary objective of the research work is to develop an effective, sensitive, economical and simple reverse phase HPLC method for quantification of Sarecycline and its impurities in Sarecycline parenteral dosage form. The separation was achieved by using a stationary phase water X-Bridge shield RP18 (150 × 4.6 mm, 3.5μ) and the mobile phase consists of ammonium acetate buffer and acetonitrile in the proportion of gradient elution. The flow rate was 1.0 mL/min. Sarecycline was detected by using UV detector at the wavelength of 240 nm. The column temperature was maintained at 40°C and sample cooler temperature was maintained at 5°C, injection volume 10μL, run time was 45 minutes. The developed method was validated for various parameters as per ICH guidelines like accuracy, precision, linearity, specificity, solution stability.