Calcipotriol (1S, 3R, 5Z, 7E, 22E, 24S)-24-Cyclopropyl-9, 10 secochola-5,7,10 (19), 22-tetraene-1,3,24-triol is a non-steroidal antipsoriatic agent derived from vitamin D. An accurate and precise high performance liquid chromatography assay has been established for determination of calcipotriol, impurities and degradation products in ointment and cream. Drug products were determined on a C₁₈ reversed-phase column with UV detection. The extracts of calcipotriol were prepared by twofold extraction with anhydrous ethanol. The method was statistically validated for linearity, accuracy, precision and selectivity. The linearity for assay of calcipotriol was confirmed in the range 5.1 µg/ml to 15.3 µg/ml. The linearity for the identified impurities was established in the range 0.05 µg/ml to 0.15 µg/ml for impurity A and B, and 0.03 µg/ml to 0.08 µg/ml for impurity D. The mean extraction recovery for the active substance and known impurities was 99.0%. The stability of calcipotriol during processing (autosampler) and in the extract was checked. The method was used for the routine analysis of calcipotriol in cream and ointment.

Reference:

1. Cirunay J.J, Vander Heyden Y., Plaizier-Vercammen J.; ,, LC separation of calcitriol from its photodegradation products and protection possibilities using adjuvants,,; J. Pharm. Biomed. Anal. 2001 August; 26(1): 31-41

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