A new, validated, and selective RP-HPLC technique was established for quantitative estimation of Dicyclomine HCl and Simethicone in the pharmaceutical oral liquid drop formulations. The chromatographic conditions were adjusted using Luna C18 (25 cm × 0.46 cm, 5 μm) column, water-methanol mixture (80:20, v/v) as solvent system and pH adjustment up to 7.4 using orthophosphoric acid. The absorbance was observed at 289 nm λmax injecting 20 μl sample solution and maintain the ambient temperature (30 °C) with 1 ml per min flow rate. The retention times of Dicyclomine HCl and Simethicone were determined 2.962 and 4.091 min, respectively. The developed analytical technique was validated for accuracy, precision, linearity, specificity, sensitivity, ruggedness, and robustness as per ICH guidelines. The LOD was found to be 0.72 and 0.57 μg per ml for Dicyclomine HCl and Simethicone, respectively. But, LOQ was 2.19 and 1.73 μg per ml, respectively. This validated method showed good precision (RSD% < 1) with acceptable linearity (≥ 0.999). Intra- and inter-day relative RSD of retention times and AUC (area under curve) were found to be less than 2.0%. The method was also significantly useful as economic technique for simultaneous quantitative determination of Dicyclomine HCl and Simethicone in the bulk and pharmaceutical formulation.

中文翻译：

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同时估算散装和口服滴剂中双环胺盐酸盐和西甲硅油：RP-HPLC方法的开发和验证

建立了一种新的，经过验证的，选择性的RP-HPLC技术，用于定量评估口服药物滴剂中的盐酸双环明和西甲硅油。色谱条件使用Luna C18（25 cm×0.46 cm，5μm）色谱柱，水-甲醇混合物（80:20，v / v）作为溶剂系统进行调节，并使用正磷酸将pH调节至7.4。在289 nmλmax处注入20μl样品溶液观察到吸光度，并以每分钟1 ml的流速保持环境温度（30°C）。测定盐酸二环胺和二甲硅油酮的保留时间分别为2.962和4.091min。根据ICH指南，对开发的分析技术的准确性，精密度，线性，特异性，灵敏度，坚固性和耐用性进行了验证。发现LOD为0.72和0。每毫升HCl和西甲硅油分别为57μg/ ml。但是，LOQ分别为2.19和1.73μg/ ml。该经过验证的方法显示出良好的精度（RSD％<1），线性可接受（≥0.999）。发现保留时间和AUC（曲线下面积）的日内和日间相对RSD小于2.0％。该方法作为同时定量测定散装和药物制剂中的盐酸二环胺盐和西甲硅油的经济技术也非常有用。