Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Assiut University, Assiut 71526, Egypt. sameh
Talanta. 2011 May 15;84(3):666-72. doi: 10.1016/j.talanta.2011.01.066. Epub 2011 Feb 2.
A simple, reproducible and efficient dual separation mode high performance liquid chromatographic (HPLC) method was developed for simultaneous determination of antihypertensive drug combinations including; hydrochlorothiazide (HCTZ), valsartan (VAL), amiloride (AML) and captopril (CAP). The newly developed Platinum™ column, which provides a dual-mode separation with its polar and non-polar sites, was used for rapid separation of these co-administered drugs. Good resolution was obtained when Platinum™ column was used compared with C(18) column. Additionally, simple isocratic mode with mobile phase containing methanol and 0.02 mole L(-1) phosphate buffer adjusted to pH 3.0 (45:55, v/v) was used for separation. The flow rate was 0.5 mL min(-1) and effluent was monitored at 270 nm. All the investigated drugs were completely separated within less than 6 min. The linearity range obtained for the developed HPLC method was 0.5-100 μg mL(-1) with detection limits of 0.13-1.2 μg mL(-1) for all the studied drugs. The method was validated in accordance with the requirements of ICH guidelines and shown to be suitable for intended applications. The method was successfully used for determination of the studied drugs in pure form and pharmaceutical dosage forms without prior need for separation. The method is valuable for quality control laboratories for simultaneous determination of these co-administered antihypertensive drugs in binary, ternary and quaternary mixtures.
开发了一种简单、重现性好且高效的双模式高效液相色谱（HPLC）方法，用于同时测定包括氢氯噻嗪（HCTZ）、缬沙坦（VAL）、氨氯地平（AML）和卡托普利（CAP）在内的降压药组合。新开发的 Platinum™柱具有极性和非极性位点的双重分离模式，用于快速分离这些共同给药的药物。与 C（18）柱相比，使用 Platinum™柱时获得了良好的分辨率。此外，还使用包含甲醇和 0.02 摩尔 L（-1）磷酸盐缓冲液（pH 3.0，45:55，v/v）的简单等度模式进行分离。流速为 0.5 mL min（-1），在 270 nm 处检测流出物。所有研究的药物都在不到 6 分钟内完全分离。所开发的 HPLC 方法的线性范围为 0.5-100 μg mL（-1），所有研究药物的检测限为 0.13-1.2 μg mL（-1）。该方法符合 ICH 指南的要求进行了验证，证明适用于预期应用。该方法成功用于纯形式和药物制剂中研究药物的测定，无需事先分离。该方法对于质量控制实验室在二元、三元和四元混合物中同时测定这些共同给予的抗高血压药物非常有价值。
