Abstract：
A novel simple, specific, sensitive, accurate and precise reversed phase high performance liquid chromatographic method (RP-HPLC/UV) was developed and validated for the simultaneous estimation of Glycopyrronium bromide (GLY), Indacaterol acetate (IND) and Mometasone furoate (MOF) in pure form, in laboratory prepared mixtures and in pharmaceutical dosage form. Experimental design methodology was applied by using Plackett-Burman and face-centered composite designs to achieve the best resolution with minimum experimental trials. The designed model was statistically analyzed, graphically presented by surface plots and the relationships between coefficients of the derived polynomial equations were interpreted. Chromatographic separation was achieved on Inertsil ODS C18 column (250 ×4.6 mm, 5 µm) at ambient temperature using a mobile phase composed of methanol: 0.1% glacial acetic acid (pH4) in a gradient elution at a flow rate 1 mL /min. UV detection was carried out at 233 nm. Response was found to be linear in the concentration range of 20-120 µg /mL with regression coefficient (r2 = 0.999) for GLY, 50-300 µg /mL with regression coefficient (r2 = 0.9995) for IND and 50-300 µg /mL with regression coefficient (r2 = 0.9998) for MOF. The method was validated as per ICH guidelines and satisfactory results were achieved. The method was successfully applied for the analysis of the cited drugs in their fixed dose combination (FDC) pharmaceutical formulation. Statistical comparison between the results obtained by the proposed method and the reference methods for GLY, IND and MOF showed no significant difference. The developed method could be implemented in quality control aspects of the cited drugs. Four green metrics were used to evaluate the new RP-HPLC/UV method\'s greenness and compare it to other published techniques.
摘要：
一部简单的小说，具体,敏感,建立了准确、精确的反相高效液相色谱法(RP-HPLC/UV),并验证了格隆溴铵(GLY)乙酸茚卡特罗（IND）和糠酸莫米松（MOF）纯形式，在实验室制备的混合物和药物剂型。通过使用Plackett-Burman和以面部为中心的复合材料设计，应用了实验设计方法，以最少的实验试验获得最佳分辨率。对设计的模型进行统计分析,通过曲面图以图形方式表示，并解释了导出的多项式方程的系数之间的关系。在InertsilODSC18色谱柱(250×4.6mm，5µm）在环境温度下使用由甲醇：0.1％冰醋酸（pH4）组成的流动相以1mL/min的流速进行梯度洗脱。在233nm下进行UV检测。发现响应在20-120µg/mL的浓度范围内呈线性关系，对于GLY，回归系数（r2=0.999），IND为50-300µg/mL，回归系数为（r2=0.9995），MOF为50-300µg/mL，回归系数为（r2=0.9998）。该方法按照ICH指南进行了验证，取得了满意的结果。该方法已成功用于分析固定剂量组合（FDC）药物制剂中的引用药物。通过所提出的方法与GLY参考方法获得的结果进行统计比较，IND和MOF差异无统计学意义。所开发的方法可以在所引用药物的质量控制方面实施。使用四个绿色指标来评估新的RP-HPLC/UV方法的绿色度，并将其与其他已发布的技术进行比较。
