STABILITY OF CISAPRIDE IN A LIQUID DOSAGE FORM AT 2 TEMPERATURES

OBJECTIVE: TO determine the stability of cisapride in a liquid dosage form stored in plastic bottles at 2 temperatures. DESIGN: Cisapride ta blets were used to prepare a suspension in equal volumes of methylcell ulose 1% and simple syrup to yield a concentration of 1 mg/mL. The cis apride suspension was stored in 10 amber plastic prescription bottles. Five bottles were stored at room temperature (25 +/- 0.1 degrees C) a nd 5 under refrigeration (4 degrees C). Samples were drawn from each b ottle immediately after mixing (day 0), and at 7, 14, 28, 42, 56, 70, and 91 days of storage at each temperature. All samples were analyzed in duplicate on each day of analysis. Cisapride was measured by a stab ility-indicating HPLC method. RESULTS: The mean concentration of cisap ride exceeded 90% of its initial concentration throughout the 91-day s tudy period at 4 degrees C, but only during the first 28 days at 25 de grees C. No significant change in pH was observed during the study per iod. CONCLUSIONS: Cisapride was stable in a suspension for 91 days at 4 degrees C and 28 days at 25 degrees C in amber plastic prescription bottles.