Articles Accepted

EVALUATION OF DARUNAVIR ETHANOLATE AND RITONAVIR POLYMORPH IN FIXED DOSE DRUG COMBINATION PRODUCT BY VARIOUS ANALYTICAL TOOLS
by Mr. Munish Buch, 16 Sep 2022
Co-Author(s): Hasit V Vaghani

Evaluation of polymorphism for active pharmaceutical ingredient and its stability during drug product manufacturing process and storage is critical task of pharmaceutical industry. Specific polymorphic forms of active drug substance are used for tablet manufacturing. Considering Ritonavir amorphous form having higher solubility and more bio-availability, its conversion from crystalline to amorphous form is taken care by drug product manufacturing process. Various analytical tools available for evaluation of polymorphism which includes powder X-Ray diffraction study and Differential scanning calorimetry. Powder XRD technique with slow scan is used for quantitative estimation of crystalline Ritonavir in process blend. The applied method is verified for its intended use. Differential scanning calorimetry technique is applied for polymorphic evaluation of Darunavir and Ritonavir both in tablet. This research work emphasizes on polymorphic evaluation of Ritonavir in Ritonavir blend and both Darunavir ethanolate and Ritonavir in fixed dose drug combination product.

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