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首页> 外文期刊>Chemical Science International Journal >Application of Multi-criteria Decision MakingApproach and Experimental Design andDevelopment of Stability-indicating UPLC Methodfor Simultaneous Determination of LosartanPotassium and Hydrochlorothiazide in Bulk andTablet Dosage Form
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Application of Multi-criteria Decision MakingApproach and Experimental Design andDevelopment of Stability-indicating UPLC Methodfor Simultaneous Determination of LosartanPotassium and Hydrochlorothiazide in Bulk andTablet Dosage Form

机译：多指标决策方法的应用和稳定性指示UPLC方法的设计与开发，用于同时测定散装和片剂剂量的氯沙坦钾和氢氯噻嗪

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This paper describes a multi response optimization methodology in combination with experimental design as a powerful technique for development of a RP-UPLC method for the simultaneous determination of losartan potassium and hydrochlorothiazide in combined dosage forms. The response surface design by means of 2~(4) full factorial design was used taking resolution, symmetry of two peaks, and two retention factors as the responses with four important factors, pH of the mobile phase, percentage of the organic modifier, buffer concentration and column temperature, were used to design mathematical models. Derringer’s desirability function was used for reaching a suitable compromise among the responses. Optimal conditions included mobile phase consisting of acetonitrile–acetate buffer 38:62 v/v, pH 5.25 and buffer concentration of 28 mM as the mobile phase and at a flow rate of 0.3 ml/min and a column temperature of 37°C. The calibration plot was linear over the concentration ranges of 0.05–7 μg/mL for Losartan and 0.0125-4 μg/mL for hydrochlorothiazide having correlation coefficients not less than 0.999. Limits of detection and quantification were 0.287, 0.869 μg/mL and 0.487, 1.47 μg/mL, for Losartan and hydrochlorothiazide respectively. The specificity and stability-indicating capability of the method was proven through forced degradation studies, which showed no interference of the excipients. The robustness of the method was evaluated by Youden and Steiner’s robustness test. The method is simple, rapid, and robust for simultaneous determination of losartan potassium and hydrochlorothiazide with minimum amount of solvent mobile phase and shortest run time about 4.5 min.
机译：本文介绍了一种结合实验设计的多响应优化方法，作为开发可同时测定组合剂型中氯沙坦钾和氢氯噻嗪的RP-UPLC方法的有力技术。采用2〜（4）全因子设计的响应面设计，将分离度，两个峰的对称性和两个保留因子作为响应，其中四个重要因素是流动相的pH值，有机改性剂的百分比，缓冲液浓度和柱温用于设计数学模型。 Derringer的可取性函数用于在响应之间达成适当的折衷。最佳条件包括流动相，流动相为乙腈-乙酸盐缓冲液38:62 v / v，pH 5.25，缓冲液浓度为28 mM作为流动相，流速为0.3 ml / min，柱温为37°C。洛沙坦的浓度范围为0.05–7μg/ mL，氢氯噻嗪的浓度范围为0.0125-4μg/ mL，线性关系的线性关系不小于0.999。氯沙坦和氢氯噻嗪的检出限和定量限分别为0.287、0.869μg/ mL和0.487、1.47μg/ mL。通过强制降解研究证明了该方法的特异性和稳定性，这表明赋形剂没有干扰。该方法的鲁棒性由Youden和Steiner的鲁棒性测试评估。该方法简便，快速，可靠，可同时测定氯沙坦钾和氢氯噻嗪，溶剂流动相的量最少，最短运行时间约为4.5分钟。

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