Stability-Indicating RP-HPLC Method for Analysis of Paracetamol and Tramadol in a Pharmaceutical Dosage Form

R. Kamble, S. Singh
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引用次数: 30

Abstract

A simple, isocratic, rapid and accurate reversed phase high performance liquid chromatography method was developed for the quantitative determination of paracetamol and tramadol in commercial medicinal tablets. The chromatographic separation was achieved on an Intersil C18 (250 mm x 4.6 mm, 5μm) column using water pH 3.4 with orthophosphoric acid: methanol (60:40, v/v) as a mobile phase, and UV detection at 228 nm. The chromatographic resolutions between paracetamol and tramadol were found greater than five. The linear range for paracetamol and tramadol were 20.8–39.0 μg/ml and 2.4–4.5 μg/ ml was obtained with correlation coefficients ≥0.999 for each analyte. The retention time were found to be 2.1 and 3.9 min for tramadol and paracetamol respectively. Paracetamol and tramadol was subjected to stress conditions (hydrolysis (acid, base) oxidation, photolysis and thermal degradation) and the stressed samples were analyzed by use of the method. The major degradation was observed in acid and minor in base, thermal, oxidation and photolysis. The forced degradation studies prove the stability indicating power of the method.
稳定性指示反相高效液相色谱法分析药品剂型中对乙酰氨基酚和曲马多
建立了一种简单、等容、快速、准确的反相高效液相色谱法测定市售片剂中扑热息痛和曲马多的含量。色谱柱为Intersil C18 (250 mm × 4.6 mm, 5μm),水pH为3.4,正磷酸:甲醇(60:40,v/v)为流动相,228 nm紫外检测。对乙酰氨基酚和曲马多的色谱分辨度大于5。对乙酰氨基酚和曲马多的线性范围分别为20.8 ~ 39.0 μg/ml和2.4 ~ 4.5 μg/ml,相关系数≥0.999。曲马多和扑热息痛的滞留时间分别为2.1 min和3.9 min。对扑热息痛和曲马多进行了水解(酸、碱)氧化、光解和热降解等应激条件,并采用该方法对应激样品进行了分析。在酸、热、氧化、光解过程中主要发生降解,在碱、热、氧化、光解过程中次要发生降解。强迫退化研究证明了该方法的稳定性和指示力。
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来源期刊
E-journal of Chemistry
E-journal of Chemistry CHEMISTRY, MULTIDISCIPLINARY-
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