A New RP-UPLC Method for Simultaneous Quantitative Estimation of Bisoprolol Hemifumarate and Hydrochlorothiazide in Tablets Using Experimental Design and Optimization

作者：Dinc Erdal^*; Ertekin Zehra Ceren; Rouhani Ghazal

来源：Journal of Liquid Chromatography & Related Technologies, 2015, 38(9): 970-976.

DOI：10.1080/10826076.2014.999200

• RP-UPLC method
• experimental design and optimization
• tablets
• hydrochlorothiazide
• quantification
• bisoprolol hemifumarate

A new reverse phase ultra-performance liquid chromatography (RP-UPLC) method was developed for the quantification of bisoprolol hemifumarate (BIS) and hydrochlorothiazide (HCT) in tablets using experimental design and optimization. In the development of method, a 3(3) full factorial design was used to identify the effects of factors (column temperature, flow rate, and 0.1M H3PO4 % in mobile phase) and their interactions on the chromatographic response and to determine optimal chromatographic conditions providing a good peak elution and shortest runtime, respectively. For the optimal RP-UPLC conditions, 58.2 degrees C (column temperature), 0.37mL/min (flow rate) and 23.6% (0.1M H3PO4) were obtained from the results of 3(3) full factorial design. The separation of BIS (retention time: 0.323min) and HCT (retention time: 0.409min) was performed within a short runtime of 0.6min. Calibration curves for BIS and HCT in the range 8.0-40.0 mu g/mL and 2.0-26.0 mu g/mL were computed by the detection at 225nm. The validity of the method was achieved by analyzing the test samples, and using inter-days and intra-day studies. Under optimal conditions, new RP-UPLC method was successfully applied for the analysis of BIS and HCT in commercial tablets.

• 出版日期2015-5-28