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


DİNÇ E., ERTEKİN ÖZKAN Z. C., Rouhani G.

JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES, cilt.38, sa.9, ss.970-976, 2015 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 38 Sayı: 9
  • Basım Tarihi: 2015
  • Doi Numarası: 10.1080/10826076.2014.999200
  • Dergi Adı: JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.970-976
  • Anahtar Kelimeler: RP-UPLC method, experimental design and optimization, tablets, hydrochlorothiazide, quantification, bisoprolol hemifumarate, COMBINATION THERAPY, DOSAGE FORMS, HUMAN PLASMA, FUMARATE, HYPERTENSION
  • Ankara Üniversitesi Adresli: Evet

Özet

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.