Abstract
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.
Highlights
Congestive heart failure (HF) is an important health care problem across the world [1]. e prevalence of HF is 1-2% in developed countries and is expected to rise even further in the decades [2, 3]
Diuretic therapy is an essential part of the management of the majority of patients with HF [4]
Diuretic resistance is common in patients with acute HF and is associated with an increased risk of morbidity and mortality. e current strategies to overcome diuretic resistance include restriction of sodium intake, coadministration regimens, continuous diuretic infusions, and mechanical ultrafiltration [11, 12]
Summary
Congestive heart failure (HF) is an important health care problem across the world [1]. e prevalence of HF is 1-2% in developed countries and is expected to rise even further in the decades [2, 3]. Erefore, specific information on drug stability in various solutions, individually or associated, is necessary to ensure patient’s safety Analytical methods for their quality control are interesting as part of hospital-based quality control of the five cardiovascular agents in their injection dosage form and for drug stability study and intravenous admixture preparation error monitoring. Various analytical methods have been developed for individual quantification of DPM, DBM, PTM, FSM, or APL, or in combination with other drugs by HPLC [19,20,21,22,23,24,25,26,27,28,29]. Our study endeavors to develop and validate a reversed-phase HPLC method for simultaneous quantification of DPM, DBM, PTM, FSM, and APL in infusion samples and in the injection dosage form. To the extent of our knowledge, no analytical method based on reversed-phase HPLC has been reported so far for the simultaneous estimation of the mixture containing DPM, DBM, PTM, FSM, and APL. erefore, the current study was aimed to develop a rapid, simple, and reproducible reversedphase HPLC method for simultaneous quantification of the above five cardiovascular drugs in infusion samples and in injection dosage form and to determine the stability of the five cardiovascular drugs, diluted with 0.9% sodium chloride or 5% glucose injection and packaged in polypropylene syringes for 48 hours (2 days) at 25°C
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