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Stability of Lisinopril Syrup (2 mg/mL) Extemporaneously Compounded from Tablets

Author(s):  Rose Deidra J, Webster Andrew A, English Brett A, McGuire J Michael

Issue:  Sep/Oct 2000 - Compounding for Immune System Disorders
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Page(s):  398-399

Stability of Lisinopril Syrup (2 mg/mL) Extemporaneously Compounded from Tablets Page 1
Stability of Lisinopril Syrup (2 mg/mL) Extemporaneously Compounded from Tablets Page 2

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Abstract:  The stability of lisinopril syrup (2 mg/mL) extemporaneously compounded from tablets was investigated. Zestril® tablets (Lot CSC201, Zeneca Pharmaceuticals, Wilmington, Del) were crushed, dissolved in water, filtered, and diluted with syrup NF to a final nominal concentration of 2 mg/mL. The solution was then equally divided among amber-colored prescription bottles and was stored at 5°C and 23°C. During the 30-day study period, samples were extracted by means of a water:methanol mix, and the concentration of lisinopril was determined by a stability-indicating, highperformance liquid chromatography assay procedure. Stability was also determined by pH measurements and visual inspection for color or clarity change. Over the 30- day study period, the percentage of the initial lisinopril concentration remained between 99.42% ± 0.19% and 95.68% ± 1.5% for the 5°C samples and 98.83% ± 0.46% and 96.48% ± 0.62% for the 23°C samples.

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