METHOD DEVELOPMENT AND VALIDATION OF RP- HPLC IN THE APPLICATION OF IN-VITRO DISSOLUTION STUDY OF EMTRICITABINE IN BULK DRUG AND TABLET FORMULATION
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 2
Abstract
A new RP-HPLC method was developed for the determination of Emtricitabine in the bulk drug and tablet dosage forms and it was applied for the in vitro drug dissolution studies. Isocratic elution mode with a mixture of methanol and water in the ratio of (89:11) was selected as the mobile phase with a C18 column (250 x 4.6mm, 5µ ) for separation. This mixture was found to be appropriate allowing good elution for the Emtricitabine at retention time 2.72 minute at flow rate of 1 ml/min and detection wavelength at 272nm. The linearity was found in the concentration range of Emtricitabine 5-100 µ g/ml. The liquid chromatography method was extensively validated for linearity, range, accuracy, precision (intermediate precision, repeatability) and specificity. All these analytical validation parameters were observed and the %RSD was determined which indicates the useful of RP-HPLC method for determination of Emtricitabine in the bulk drug & tablets dosage form.
Authors and Affiliations
Brajendra Rajpoot , Neha Rajpoot
Keywords
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