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.
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