Simultaneous Quantitative Analysis of Six Proton-Pump Inhibitors with a Single Marker and Evaluation of Stability of Investigated Drugs in Polypropylene Syringes for Continuous Infusion Use

Abstract

Objective We developed and validated a simple, convenient and reproducible method for simultaneous estimation of six proton-pump inhibitors (PPIs), omeprazole (OPZ), esomeprazole (EOPZ), lansoprazole (LPZ), pantoprazole (PPZ), rabeprazole (RPZ) and ilaprazole (IPZ) in pharmaceutical dosage forms by a single marker. Meanwhile, the stability of the cited PPIs in 0.9% sodium chloride injection stored in polypropylene syringes up to 48 hours for continuous infusion use was investigated. Materials and Methods The chromatographic separation was achieved on an InterSustain ® C 18 column (150 × 4.6 mm, 5 μm). The isocratic mobile phase made up of 0.05 M potassium dihydrogen phosphate buffer (pH 4.0): acetonitrile (65:35, v/v) was pumped through the column at a temperature maintained at 30°C and a flow rate of 1.0 mL/min. The relative retention time, UV spectral similarity and relative correction factors between OPZ and the other five PPIs were calculated and investigated using the quantitative analysis of multi-components with a single marker (QAMS) method. The stability study examined physical parameters, pH values and drug concentrations of the PPIs mixtures. Results Under these conditions, all cited PPIs were separated simultaneously at a retention time of 6.0, 7.3, 7.3, 9.9, 12.5 and 13.9 min for RPZ, OPZ, EOPZ, IPZ, PPZ and LPZ, respectively, with a total run time less than 20.0 min. Comparative analysis results indicated that there were no significant differences observed between the QAMS method and the external standard method. The percentage of initial concentration of each PPI gradually decreased during the storage time. Conclusion The proposed method, which is selective, economical and accurate, was applied successfully for determination of the cited PPIs in their respective pharmaceutical dosage forms. Admixtures of OPZ, EOPZ, PPZ, IPZ in 0.9% sodium chloride injection were stable for 24 hours and LPZ, RPZ in 0.9% sodium chloride injection were stable for 8 hours in polypropylene syringes.

Simultaneous determination of five diuretic drugs using quantitative analysis of multiple components by a single marker

“…Inspired by the HPLC-based ESM analytical method, QAMS uses a single component as the internal standard to simultaneously quantitatively measure itself and other analytes by calculating relative correction factors (RCFs). In recent decades, the QAMS method has been widely used in the evaluation of a large number of Chinese herbal medicines [ 22 – 28 ], drugs [ 29 ] and drug impurities [ 31 , 32 ]. In this study, etacrynic acid was chosen as an internal reference to calculate the RCF of the other four diuretics.…”

“…The above mentioned methods, however, have not been employed for the simultaneous quantification of the five LDs in any pharmaceutical formulation. The QAMS method is able to simultaneously determine the concentrations of multiple components by a single reference standard, which greatly reduces the cost and reduction of the analysis time of the experiment [ 22 – 29 ]. Thus, the present study developed a rapid HPLC-QAMS method for the determination of the five LDs.…”

A Fast and Validated HPLC Method for the Simultaneous Analysis of Five 5-HT3 Receptor Antagonists via the Quantitative Analysis of Multicomponents by a Single Marker

“…The relative correction factors (RCF, f) between ODT and the other 5-HT 3 receptor antagonists were calculated using equation ( 3 ). The concentration of each 5-HT 3 receptor antagonist in the sample solution can be calculated using equation ( 4 ) [ 25 – 32 ]. where A i is the peak area of an internal reference substance (ODT) under test, and C i is the concentration of internal reference substance under test.…”

“…e relative correction factors (RCF, f) between ODTand the other 5-HT 3 receptor antagonists were calculated using equation (3). e concentration of each 5-HT 3 receptor antagonist in the sample solution can be calculated using equation ( 4) [25][26][27][28][29][30][31][32].…”

“…To solve the above problems, a unique quantitative analysis of multicomponents by a single marker (QAMS) analytical method was adopted in this paper. e QAMS method is able to simultaneously identify and quantify itself and the other analytes by a single reference standard, which greatly reduces the cost and analysis time of the experiment [25][26][27][28][29][30][31][32]. To date, there are no reports concentrating the QAMS or ESM method on the simultaneous quantification of ODT, GNT, TPT, AZT, and RMT in infusion samples and in injection dosage form.…”