摘要
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.
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.
