Simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form by capillary zone electrophoresis

Abstract

A novel, specific, reliable, and accurate capillary zone electrophoretic method was developed and validated for the simultaneous determination of aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide in their triple mixture dosage form. Separation was carried out in a fused-silica capillary (57.0 cm total length and 50.0 cm effective length, 75.6 μm internal diameter) by applying a potential of 17 kV and a running buffer consisting of 40 mM phosphate buffer at pH 6.0 with UV detection at 245 nm. The method was suitably validated with respect to specificity, linearity, LOD, and LOQ, accuracy, precision, and robustness. The method showed good linearity in the ranges 1-10, 2.5-25, and 30-300 μg/mL with LODs of 0.11, 0.33, and 5.83 μg/mL for amlodipine besylate, hydrochlorothiazide, and aliskiren hemifumarate, respectively. The proposed method was successfully applied for the analysis of the studied drugs in their coformulated tablets. The results of the proposed method were statistically compared with those obtained by the RP-HPLC reference method revealing no significant differences in the performance of the methods regarding accuracy and precision.

Quality testing of human albumin by capillary electrophoresis using thermally cross‐linked poly(vinyl pyrrolidone)‐coated fused‐silica capillary

“…In addition, the separation of the four basic proteins with concentration range from 0.01 to 0.5 mg/mL was performed to detect the LOD and LOQ in the protein mixture. The LOD and LOQ were calculated according to ICH Q2 (R1) recommendations using the following equations: LOD = 3.3 S a / b and LOQ = 10 S a / b , where S a is the SD of the calibration curve's intercept and b is the slope of the calibration curve . The results of the proteins’ LOD in the mixture (as shown in Table ) was <10 μg/mL except ribonuclease A, which is similar to the study of Srinivasan .…”

Mean centering of double divisor ratio spectra, a novel spectrophotometric method for analysis of ternary mixtures

“…There are reported methods for the determination of AML, ALI or HCT in different dosage forms [27][28][29][30][31]. AML, ALI and HCT were simultaneously determined in their ternary mixture by HPLC and capillary electrophoresis [32,33]. Two derivative spectrophotometric methods were developed for the determination of this mixture by the authors [34].…”

A green capillary zone electrophoresis method for the simultaneous determination of piperacillin, tazobactam and cefepime in pharmaceutical formulations and human plasma

“…The advantages of using CE include its speed and low cost of analysis, reductions in solvent consumption and disposal, and the possibility of rapid method development (Hendrickx et al ., ; Altria et al ., ). Recently, CE techniques have been applied to the simultaneous determination of co‐formulated drugs in dosage form (Alnajjar, ; Barden et al ., ; Salim et al ., ).…”