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首页> 外文期刊>Acta Poloniae Pharmaceutica: Durg Research >RAPID AND SENSITIVE BIOANALYTICAL STABILITY-INDICATING METHOD FOR QUANTIFICATION OF TALINOLOL, A SELECTIVE beta 1 ADRENOCEPTOR ANTAGONIST IN LIPID BASED FORMULATIONS USING ULTRAFAST UHPLC SYSTEMS
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RAPID AND SENSITIVE BIOANALYTICAL STABILITY-INDICATING METHOD FOR QUANTIFICATION OF TALINOLOL, A SELECTIVE beta 1 ADRENOCEPTOR ANTAGONIST IN LIPID BASED FORMULATIONS USING ULTRAFAST UHPLC SYSTEMS

机译：快速，灵敏的生物分析稳定性指示方法，用于通过超声快速超高效液相色谱系统定量的脂质体中塔林洛尔（一种选择性的β1受体拮抗剂）

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摘要

The current study evaluates the ultra high performance liquid chromatography (UHPLC) method for the quantification of talinolol in lipid-based formulations. A simple, rapid, reliable and precise reversed phase UHPLC method has been developed and validated according to the regulatory guidelines, which was composed of isocratic mobile phase; acetonitrile and phosphate buffer saline (pH 4.5) with a flow rate of 0.4 mL/min, and column HSS C-18 (2.1 x 50 mm, 1.8 mu m). The detection was carried out at 245 nm. The developed UHPLC method was found to be rapid (1.8 mm run time), selective with high resolution of talinolol peak (0.88 min) from different lipid matrices and highly sensitive (limit of detection and lower limit of quantification were 0.14 ppm and 0.5 ppm, respectively). The linearity, accuracy and precision were determined as acceptable over the concentration range of 0.5-100 ppm for talinolol. The results showed that the proposed UHPLC method can be used for the estimation of talinolol in lipid-based formulation by indicating its purity and stability with no interference of excipients or related substances of active pharmaceutical ingredient.
机译：当前的研究评估了超高效液相色谱（UHPLC）方法，用于定量基于脂质的制剂中的塔利诺尔。已经开发了一种简单，快速，可靠和精确的反相超高效液相色谱方法，并根据法规指南进行了验证，该方法由等度流动相组成。流速为0.4 mL / min的乙腈和磷酸盐缓冲盐水（pH 4.5）和HSS C-18色谱柱（2.1 x 50 mm，1.8μm）。检测在245nm进行。发现开发的UHPLC方法快速（运行时间为1.8 mm），对不同脂质基质的塔利诺尔峰具有高分辨率（0.88分钟）的选择性，并且灵敏度很高（检测限和定量下限分别为0.14 ppm和0.5 ppm，分别）。塔林洛尔在0.5-100 ppm的浓度范围内的线性，准确度和精密度确定为可接受。结果表明，所提出的UHPLC方法可通过显示其纯度和稳定性而不受赋形剂或活性药物成分相关物质的干扰，从而可用于估算基于脂质的制剂中的塔利诺尔。

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