A simple, fast, and validated HPLC method was developed for the simultaneous quantization of five cardiovascular agents: dopamine (DPM), dobutamine (DBM), phentolamine (PTM), furosemide (FSM), and aminophylline (APL) either in infusion samples or in an injection dosage form. The proposed method was achieved with a 150 mm × 4.6 mm, 5.0 μm C₁₈ column, by using a simple linear gradient. Mobile phase A was buffer (50 mM KH₂PO₄) and mobile Phase B was acetonitrile at a flow rate of 1.0 mL/min. The column temperature was kept at 30°C, and the injection volume was 20 μL. All analytes were separated simultaneously at a retention time (tr) of 3.93, 5.84, 7.06, 8.76, and 9.67 min for DPM, DBM, PTM, FSM, and APL, respectively, with a total run time of less than 15.0 min. The proposed method was validated according to ICH guidelines with respect to accuracy, precision, linearity, limit of detection, limit of quantitation, and robustness. Linearity was obtained over a concentration range of 12.0–240.0, 12.0–240.0, 20.0–200.0, 6.0–240.0, and 10.0–200.0 μg/mL DPM, DBM, PTM, FSM, and APL, respectively. Interday and intraday accuracy and precision data were recorded in the acceptable limits. The new method has successfully been applied for quantification of all five drugs in their injection dosage form, infusion samples, and for evaluation of the stability of investigated drugs in mixtures for endovenous use. The results of the stability study showed that mixtures of DPM, DBM, PTM, FSM, and APL in 5% glucose or 0.9% sodium chloride injection were stable for 48 hours when stored in polypropylene syringes at 25°C.

中文翻译：

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快速，高效液相色谱法同时测定输注样品和注射剂中的多巴胺，多巴酚丁胺，酚妥拉明，速尿和氨茶碱

开发了一种简单，快速且经过验证的HPLC方法，用于同时定量分析输注样品或注射液中的五种心血管药物：多巴胺（DPM），多巴酚丁胺（DBM），苯妥拉明（PTM），速尿（FSM）和氨茶碱（APL）在注射剂型中。所提出的方法，用150mm的×4.6毫米，5.0实现 μ M C ₁₈柱，通过使用简单的线性梯度。流动相A为缓冲液（50 mM KH ₂ PO ₄），流动相B为乙腈，流速为1.0 mL / min。柱温保持在30°C，进样量为 20μL.所有分析物在DPM，DBM，PTM，FSM和APL的保留时间（tr）分别为3.93、5.84、7.06、8.76和9.67分钟的同时分离，总运行时间少于15.0分钟。根据ICH指南，在准确性，精度，线性，检测限，定量限和鲁棒性方面验证了该方法的有效性。线性度超过12.0-240.0，12.0-240.0，20.0-200.0，6.0-240.0的浓度范围内获得，和10.0-200.0  μg / mL DPM，DBM，PTM，FSM和APL。日间和日内准确性和精密度数据均记录在可接受的范围内。该新方法已成功应用于所有五种药物的注射剂型，输液样品的定量，以及用于静脉内使用的混合物中所研究药物的稳定性评估。稳定性研究的结果表明，DPM，DBM，PTM，FSM和APL在5％葡萄糖或0.9％氯化钠注射液中的混合物在25°C的聚丙烯注射器中储存时可稳定48小时。