scholarly journals Development and validation of an HPLC method using an experimental design for analysis of amlodipine besylate and enalapril maleate in a fixed dose combination

2020 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
Diren SARISALTIK-YASIN ◽  
Alev ARSLANTURK-BINGUL ◽  
Alptug KARAKUCUK ◽  
Zeynep Safak TEKSIN
Keyword(s):  
Experimental Design ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Amlodipine Besylate ◽  
Enalapril Maleate ◽  
Dose Combination ◽  
Development And Validation

scholarly journals Development and validation of an HPLC method for the simultaneous determination of artesunate and mefloquine hydrochloride in fixed-dose combination tablets

2013 ◽  
Vol 49 (4) ◽  
pp. 837-843 ◽  
Author(s):  
Fernando Henrique Andrade Nogueira ◽  
Naialy Fernandes Araújo Reis ◽  
Paula Rocha Chellini ◽  
Isabela da Costa César ◽  
Gerson Antônio Pianetti
Keyword(s):  
Simultaneous Determination ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Array Detector ◽  
Control Analysis ◽  
Dose Combination ◽  
Development And Validation

The present study developed and validated an HPLC method for the simultaneous determination of artesunate (AS) and mefloquine hydrochloride (MQ) in fixed-dose combination tablets, according to ICH guidelines. The chromatographic separation was carried out on an XBridge C18 (250 x 4.6 mm i.d., 5 µm particle size, Waters) analytical column. The mobile phase included a 0.05 M monobasic potassium phosphate buffer (pH adjusted to 3.0 with phosphoric acid) and acetonitrile (50 + 50, v/v). The flow rate was 1.0 mL/min, and the run time was 13 minutes. A dual-wavelength approach was employed: AS detection was performed at 210 nm and MQ was detected at 283 nm, using a diode array detector. Stability of sample solutions was evaluated for 8 hours after preparation, during which time the solutions remained stable. Youden's test was employed to evaluate robustness. The method proved to be linear (r²>0.99), precise (RSD<2.0%), accurate, selective, and robust, proving to be appropriate for routine drug quality control analysis.

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