Simultaneous Determination of Artesunate and Amodiaquine in Fixed-Dose Combination by a RP-HPLC Method with Double UV Detection: Implementation in Interlaboratory Study Involving Seven African National Quality Control Laboratories

2012 ◽  
Vol 75 (11-12) ◽  
pp. 617-628 ◽  
Author(s):  
Y. Le Vaillant ◽  
C. Brenier ◽  
Y. Grange ◽  
A. Nicolas ◽  
P. A. Bonnet ◽  
...  
2008 ◽  
Vol 48 (3) ◽  
pp. 951-954 ◽  
Author(s):  
Isabela da Costa César ◽  
Fernando Henrique Andrade Nogueira ◽  
Gérson Antônio Pianetti

2013 ◽  
Vol 12 (1) ◽  
pp. 145 ◽  
Author(s):  
Sultan Suleman ◽  
Kirsten Vandercruyssen ◽  
Evelien Wynendaele ◽  
Matthias D’Hondt ◽  
Nathalie Bracke ◽  
...  

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

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.


2018 ◽  
Vol 42 (4) ◽  
pp. 2459-2466 ◽  
Author(s):  
N. Singh ◽  
P. Bansal ◽  
M. Maithani ◽  
Y. Chauhan

A simple and precise stability indicating method for the simultaneous estimation of dapagliflozin and saxagliptin in combined tablet dosage form was developed and validated using RP-HPLC.


2019 ◽  
Vol 10 (3) ◽  
pp. 218-223
Author(s):  
Hany Hunter Monir ◽  
Adel Magdy Michael ◽  
Christine Kamal Nessim ◽  
Yasmin Mohamed Fayez ◽  
Nahla Salah Elshater

New, validated and accurate reversed phase HPLC method with UV detection has been established for simultaneous determination of a veterinary binary mixture of doxycycline hydrochloride (DOX) and tylosin tartrate (TYT). The stationary phase was ACE- 126-2546 AQ C-18 (250 × 4.6 mm i.d., 5 μm particle size) column at 25 °C, in an isocratic mode, using mobile phase containing a mixture of methanol: acetonitrile: distilled water in the ratio of 60:20:20 (v:v:v), with 0.01% trichloroacetic acid at the flow rate of 0.8 mL/min and UV detection was performed at 270 nm. The retention times were 4.02±0.01 and 5.62±0.01 mins for DOX and TYT, respectively. Selective determination of the cited veterinary drugs has been developed in their formulation. The method was found to be linear over 1-50 µg/mL for DOX and TYT with mean percentage recoveries 99.62±1.220 and 100.09±1.104%. The method was proven to be accurate, precise and specific. The obtained results were statistically compared with those of the official and reported methods; using Student’s t test, F test and one-way ANOVA, showing no significant difference with high accuracy. Specificity of the applied method was assessed by analysing the laboratory-prepared mixtures and their combined dosage form. The developed method was confirmed according to ICH guidelines. The validated method can be considered as alternative and basic method for the routine determination of this fixed dose combination with minimum sample preparation.


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