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Concurrent chromatographic determination of pseudoephedrine and loratadine from combination syrups and tablets
Future Journal of Pharmaceutical Sciences Pub Date : 2021-07-08 , DOI: 10.1186/s43094-021-00287-3
Imad Osman Abu Reid 1
Affiliation  

Chromatographic separation of polar and nonpolar compounds when presented in combined dosage forms has always been considered as great analytical challenge. Separation and retention of both polar and nonpolar compounds by the same stationary phase can be a useful approach for analyses of complex samples with such a difference in chemical properties. Loratadine (nonpolar) and pseudoephedrine (polar) are typical examples of this situation. The Box–Behnken design was used to optimize the separation process, an efficient separation of loratadine and pseudoephedrine was achieved within 6 min; employing a mixture of 16.0 mM ammonium acetate buffer (pH 4.5) and acetonitrile (23:77, v/v) as isocratic mobile phase, pumped at 1.0 mL/min through a Zorbax cyanopropyl column (250 mm × 4.6 mm, 5 μm), the analytes were detected at 250 nm. Under the same conditions, separation of sodium benzoate preservative co-formulated with the two analytes in syrup formulation was also achieved. The calibration curve demonstrated excellent linearity in the range of 24.6–123.2 μg/mL and 594.8–2974.0 μg/mL for loratadine and pseudoephedrine, respectively with determination coefficient (r2) > 0.999. The method’s accuracy bias < 2.0%, repeatability and intermediate precision (%RSD < 2.0%) were verified. In addition, system suitability parameters were found within the acceptable limits. Satisfactory results were obtained upon the application of the validated method to the analysis of commercial tablet and syrup formulations.

中文翻译:

同时色谱测定复方糖浆和片剂中的伪麻黄碱和氯雷他定

当以组合剂型存在时,极性和非极性化合物的色谱分离一直被认为是一项巨大的分析挑战。通过相同的固定相分离和保留极性和非极性化合物对于分析具有如此不同化学性质的复杂样品是一种有用的方法。氯雷他定(非极性)和伪麻黄碱(极性)是这种情况的典型例子。Box-Behnken 设计用于优化分离过程,在 6 分钟内实现了氯雷他定和伪麻黄碱的有效分离;使用 16.0 mM 醋酸铵缓冲液 (pH 4.5) 和乙腈 (23:77, v/v) 的混合物作为等度流动相,以 1.0 mL/min 的速度泵入 Zorbax 氰丙基柱(250 mm × 4.6 mm,5 μm) ,分析物在 250 nm 处检测到。在相同条件下,还实现了糖浆制剂中与两种分析物共同配制的苯甲酸钠防腐剂的分离。氯雷他定和伪麻黄碱的校准曲线在 24.6–123.2 μg/mL 和 594.8–2974.0 μg/mL 范围内表现出优异的线性,决定系数 (r2) > 0.999。验证了该方法的准确度偏差 < 2.0%、重复性和中间精密度 (%RSD < 2.0%)。此外,系统适用性参数在可接受的范围内。将经过验证的方法应用于商业片剂和糖浆制剂的分析,获得了令人满意的结果。氯雷他定和伪麻黄碱的校准曲线在 24.6–123.2 μg/mL 和 594.8–2974.0 μg/mL 范围内表现出优异的线性,决定系数 (r2) > 0.999。验证了该方法的准确度偏差 < 2.0%、重复性和中间精密度 (%RSD < 2.0%)。此外,系统适用性参数在可接受的范围内。将经过验证的方法应用于商业片剂和糖浆制剂的分析,获得了令人满意的结果。氯雷他定和伪麻黄碱的校准曲线在 24.6–123.2 μg/mL 和 594.8–2974.0 μg/mL 范围内表现出优异的线性,决定系数 (r2) > 0.999。验证了该方法的准确度偏差 < 2.0%、重复性和中间精密度 (%RSD < 2.0%)。此外,系统适用性参数在可接受的范围内。将经过验证的方法应用于商业片剂和糖浆制剂的分析,获得了令人满意的结果。系统适用性参数在可接受的范围内。将经过验证的方法应用于商业片剂和糖浆制剂的分析,获得了令人满意的结果。系统适用性参数在可接受的范围内。将经过验证的方法应用于商业片剂和糖浆制剂的分析,获得了令人满意的结果。
更新日期:2021-07-09
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