TITLE:
Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D3 Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene
AUTHORS:
R. K. Bhogadi, A. Satyanarayana, N. Someswara Rao, Srinivas Arutla, A. Malleswara Reddy
KEYWORDS:
Calcipotriene, Pre-Calcipotriene, HPLC, Photo Isomers, Ointment
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.6 No.13,
December
25,
2015
ABSTRACT: A single RP-HPLC method is developed for estimation
of isomeric impurities of vitamin D3 analogue-Calcipotriol/Calcipotriene
(Calci) and impurities of Betamethasone dipropionate (BD). The developed method is capable of separating impurities of Calci and
BD, specifically pre-Calcipotriene (Pre-Calci) from other known and unknown impurities.
Pre-Calci is isolated and is characterised using few analytical techniques.
These impurities are separated using a RP-C18 150 × 4.6 mm, 2.7 μm column maintained at 50°C. The mobile phase consisted of mixture of water,
methanol, acetonitrile and tetrahydrofuran eluted in gradient mode. Detection
was done at 264 nm and 240 nm for Calci and BD impurities respectively. The
method can be used for determining quality of Calci and BD drugs and ointment
based drug products. It is stability indicating related substance method for
both the drugs and drug products.