Stability indicating RP-HPLC method for quantification of Eravacycline and its impurities in Eravacycline for injection
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Abstract
The main aim and objective of the research work is to develop an effective, sensitive, economical and simple reverse phase HPLC method for quantification of Eravacycline and its impurities in Eravacycline parenteral dosage form. The separation was achieved by using a stationary phase waters Primesil C18 (250 x 4.6 mm, 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. Eravacycline was detected by using UV detector at the wavelength of 210 nm. The column temperature was maintained at 40°C and sample cooler temperature was maintained at 5°C, injection volume 10 µL, run time was 60 minutes. The developed method was validated for various parameters as per ICH guidelines like accuracy, precision, linearity, specificity, solution stability.