STABILITY STUDY AND CONTENT UNIFORMITY OF PROCHLORPERAZINE IN PHARMACEUTICAL PREPARATIONS BY LIQUID-CHROMATOGRAPHY

The stability of prochlorperazine (PCZ) in pharmaceutical admixtures a nd the content uniformity of its dosage forms were examined by liquid chromatography. The drug and internal standard (imipramine) were separ ated on a CN Radial-Pak cartridge using sodium acetate solution (0.018 M)-acetonitrile (5:95, v/v) as the mobile phase, and were detected in the eluate at 250 nm. The assay was highly linear (r > 0.993), and th e relative standard deviations (R.S.D.s) at 5, 12.5 and 25 mu g/ml wer e 7.8, 4.1, and 4.3%, respectively. The deviations from perfect accura cy at these concentrations were 6.4, 1.6, and 6.0%, respectively. The mean percentages (with R.S.D.s) of the labelled claim found in a comme rcially available injection, syrup, tablet and suppository were 103.9 (3.5%), 103.8 (3.6%), 100.5 (1.5%) and 101.1 (5.0%), respectively. Alt hough the drug was stable in sterile dextrose solution (5%, w/v) at 4 degrees C (refrigeration) with protection from light, it degraded rapi dly in a bi-exponential fashion at 23 degrees C (room temperature), pa rticularly when unprotected from light. Poorer stability was observed under all conditions examined when PCZ was formulated in normal saline .