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The stability of triamcinolone in three kinds of oral liquid syrups at 4 and 25oC was studied for 21 days. Twenty tablets of 4 mg triamcinolone were mixed with 100 mL of each oral liquid syrup, which is Levotuss®Syrup (levodropropizine 6 mg/mL), Ucerax®Syrup (hydroxyzine 2 mg/mL), and Xyzal®Liquid (levocetirizine 0.5 mg/mL). The chromatographic analysis after deliberate degradation showed no evidence of any breakdown product likely to interfere with the chromatographic peak of the parent substance. The relationship between triamcinolone concentrations and peak areas was linear from 50 to 1000 μg/ mL (r2 = 0.9998). The analysis method was precise, with coefficients of variation no greater than 5.4%. Triamcinolone was stable for up to 14 and 21 days in Levotuss®Syrup at 25 and 4oC, respectively; in Ucerax®Syrup and Xyzal ®Syrup, it was stable for at least 21 days at both temperatures. The percentages of initial triamcinolone concentration remaining after 21 days were 72.3±3.2 and 94.9±6.0% and 93.2±4.9 and 92.4±5.7%, and 92.6±1.2 and 92.7±2.2% in Levotuss®Syrup, Ucerax®Syrup, and Xyzal®Syrup at 25 and 4oC, respectively. The pH variations of all test solutions were within 0.8. Based on the results, it was concluded that triamcinolone in three oral liquid syrups which are Levotuss®syrup, Ucerax®syrup and Xyzal®syrup was chemically and physically stable in both states of refrigeration and room temperature for at least 14 days.
목차
Abstract 연구방법 시약 및 재료 High Performance Liquid Chromatography 분석법 검량선 작성 및 분석법 밸리데이션 가혹시험 안정성 시험 결과처리 연구 결과 고찰 및 결론 참고문헌