<?xml version="1.0" encoding="utf-8"?>
<Journal>
<Journal-Info>
<name>International Journal of Pharma and Bio Sciences</name>
<website>ijpbs.net</website>
<email>editorijpbs@rediffmail.com (or) editorofijpbs@yahoo.com (or) prasmol@rediffmail.com</email>
</Journal-Info>
<article>
<article-id pub-id-type='other'>10.22376/ijpbs.2019.10.1.p1-12</article-id>
<issue_number>Volume 10 Issue 4</issue_number>
<issue_period>2019 (October-December)</issue_period>
<title><b>Validated chiral liquid chromatographic method for the enantiomeric separation of Tenofovir Disoproxil drug substance and its dosage forms</b></title>
<abstract>A selective isocratic liquid chromatographic method was developed for the chiral purity of Tenofovir Disoproxil and its S-enantiomer. Superior resolution between Tenofovir Disoproxil and its enantiomer was achieved on Chiralpak ADH, (25 mm × 4.6 mm, 5 μm) column using methanol: acetonitrile (90:10, v/v) containing 2 mL of dimethyl amine as a mobile phase at 30 °C column oven temperature. The USP resolution between the enantiomers was found more than five. Mobile phase flow was fixed at a rate of 1.0 mL/min and elution was monitored at 260 nm. Limit of detection and quantitative of S-enantiomer is 0.01 μg/mL and 0.3 μg/mL respectively. The method was validated for accuracy, precision, specificity, linearity, and sensitivity. Linearity was established for Tenofovir enantiomer frm 0.2µg/ml to – 2.44 µg/mL (R2 greaterThan 0.95), the limit of detection (LOD) and limit of quantitation (LOQ) was found to be 0.01 µg/ml and 0.03 µg/ml respectively for Tenofovir. %RSD below 5% was observed for precision and intermediate precision and recovery results were satisfactory.</abstract>
<authors>VIVEK TUMMALA, PROF. K. BASAVAIAH AND DR. B.M. RAO</authors>
<keywords>Tenofovir Disoproxil, Enantiomers, Chiral liquid chromatography, Validation, Specificity</keywords>
<pages>76-84</pages>
</article>
</Journal>
