RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF DEGARELIX

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Samba Praveen Kumar, Uppunoothula Kalyan, Samrin Saddam, Priyanka Raj, Rohit Kori, Dr Sepuri Vijayalaxmi

Zobrax stationary conditions are used in chromatography (160mm x5.5 mm, 5m)., portable stage ACN: Ammonium was used in a 55:45 ratio, with a detection wavelength of 310 nm, a column temperature of 30OC, and mobile phase as the diluent. A 2.79-minute retention time was discovered. Between 25% and 150% levels, linearity research was conducted, and an R2 value was discovered.0.999 is to be. The results showed that the method precision was 0.5 and the intermediate precision was 0.2. The corresponding LOD and LOQ values are

0.4 g/ml and 1.2 g/ml.

RP-HPLC, Degarelix, Method development ICH Guidelines.