U. Harini

Department of Pharmaceutical Analysis, Raghu College of Pharmacy, Dakamarri, Visakhapatnam, India

Publications

• Research Article   
  Identification of Impurities in the Drug Risankizumab Using RP-HPLC Method
  Author(s): U. Harini*
  
  Aim: To establish and validate a stability-indicating RP-HPLC method for the concurrent quantification of Risankizumab and its associated impurities in both bulk drug substances and pharmaceutical dosage forms. Specific objectives: • To develop a simple, rapid and specific RP-HPLC method for the estimation of Risankizumab and its impurities in bulk and combined pharmaceutical dosage forms. • To validate the proposed methods in accordance with the analytical parameters mentioned in the ICH guidelines, such as system suitability, accuracy, precision, specificity, linearity, robustness, LOD and LOQ. • To develop the method under the forced conditions such as acid, alkali, peroxide, reduction, thermal, hydrolysis and photo degradation. A simple, rapid, precise, sensitive and reproducible Rev.. Read More»
  

  Abstract PDF