DEVELOPMENT AND VALIDATION OF DIFFERENT SPECTROPHOTOMETRIC METHODS FOR ESTIMATION OF TENOFOVIR DISOPROXIL FUMARATE FROM BULK DRUG AND TABLETS
AbstractSimple, sensitive and accurate UV- spectrophotometric methods have been developed for the determination of an anti-HIV drug, Tenofovir Disoproxil fumarate (TDF), in raw material and in tablets. The drug shows maximum absorbance at 259 nm in selected four different media namely gastric fluid simulated (HCl) pH 1.5, vaginal fluid simulated (VFS) pH 4.2, phosphate buffer (PB) pH 6.8 and double distilled water. Beer’s law is obeyed in the concentration range of 5-45 µg/mL of drug. The limits of detection and limits of quantification are found to be 1.37 and 4.17 µg/ml in gastric fluid simulated, 1.27 and 3.85 µg/ml in vaginal fluid simulated, 1.22 and 3.71 µg/ml in phosphate buffer and 1.30 and 3.95 in double distilled water respectively. The methods have been successfully applied for the determination of TDF in tablets and bulk drugs. Results are validated statistically as per ICH guidelines. It is found that the excipients present in the commercial formulation do not interfere with the methods and hence the UV-method permits a rapid and economical quantification of drug in bulk and in tablet dosage form.
Article Information
45
623-629
416KB
986
English
IJPSR
Nita Mondal* and Yeshveer Singh
R.V. Northland Institute, Chithera, P.O. Dadri, Gautam Budh Nagar- 203 207, Uttar Pradesh, India
nitamondal@gmail.com
02 September, 2013
30 October, 2013
09 January, 2014
http://dx.doi.org/10.13040/IJPSR.0975-8232.5(2).623-29
01 January, 2014
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