METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING BARICITINIB BY RP-HPLC FOR BULK AND SOLID DOSAGE FORM
*Rucha Chopade and Rajashri V. Patil
ABSTRACT
The aim of study is to develop method and validation of Baricitinib by using RP-HPLC for bulk solid dosage form. Main objective is to develop and validate a new, simple, rapid, precise, and accurate An Eco-friendly RP-HPLC and UV-Method Development and Validation for an estimation of Baricitinib in Bulk and solid dosage form.To perform all the validation parameters according to ICH guidelines. Baricitinib belongs to class III of biopharmaceutical classification system (BCS), which means that it is highly soluble and poorly permeable drug, however, the same report also mentioned that baricitinib is practically insoluble. The analysis of the drug was carried out on Column: Phenomenex ODS-3,Column Dimension: (250 mm X 4.6 mm i.d.) 5μm Column Oven temperature: 35°C, Injection Volume: 20 μl, Wavelength: 251 nm, Mobile phase: Acetonitrile : 0.1% OPA in Water (60:40), Flow Rate: 1.0 ml/min, run time : 6 min having software open lab EZ chrome. 20 μg/mL as working concentration was used. Assay study was performed on Covinib 4mg tablet. Validation parameters like accuracy, precision, repeatabilitystudies, specificity, solubility, LOD, LOQ and stability testing was performed on Baricitinib. From the calibration curve it was concluded that the Baricitinib shows linear response in the range of 2.0-30.0 μg /ml. All the parameters were within range hence above method is validated.
Keywords: Baricitinib, HPLC, Accuracy, stability, specificity, linearity, filtration etc.
[Full Text Article]
[Download Certificate]
Impact Factor : 8.181 
