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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF TENOFOVIR DISOPROXIL FUMARATE IN BULK AND DOSAGE FORM
Yogesh P. Pawar*, Shaadmin N. Shaikh and Pratap S. Dabhade
ABSTRACT Objective of the present analytical research work was to developed and validate RP-HPLC method for the estimation of Tenofovir Disoproxil Fumarate in bulk and dosage form. Method & Results: The RP-HPLC method for Tenofovir Disoproxil Fumarate was developed using column C-18 (4.6 x 250 mm) as stationary phase Methanol: Water (0.1 %OPA (85:15 v/v) as mobile phase. The mobile phase was maintained at a flow rate of 0.7 ml/min, Temperature is Ambient, HPLC System- Younglin (S.K) Gradient System UV Detector, system- Autochro - 3000. The method was validated in accordance with ICH guidelines. Conclusion: The developed HPLC method was simple, rapid, easy, accurate and precise. So, the method can be applied successfully for the routine analysis of Tonofovir Disoproxil Fumarate in pharmaceutical industry. Keywords: Tonofovir Disoproxil Fumarate, Methanol, Water, RP- HPLC, Method Development and Validation. [Download Article] [Download Certifiate] |