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A Validated RP-HPLC Method for the Determination of Butamirate Citrate and Benzoic Acid in Syrup, Based on an Experimental Design Assessment of Robustness
- Source :
- Separations, Vol 8, Iss 163, p 163 (2021), Separations, Volume 8, Issue 10
- Publication Year :
- 2021
- Publisher :
- MDPI AG, 2021.
-
Abstract
- A reversed-phase high-pressure liquid chromatography (RP-HPLC) method was developed and subsequently validated for the simultaneous determination of butamirate citrate (BC) and benzoic acid (BA) in cough syrup. The separation was performed employing a cyanopropyl column with a mobile phase consisting of 50%/50% v/v MeOH/NaH2PO4 * H2O 50 mM aqueous solution pH = 3.0. The quantitation was achieved with a diode array detector (DAD) at 210 nm. The method demonstrated a congenitally satisfactory separation, yet the acquired peaks were asymmetrical. This effect was eliminated by using 1% triethylamine in the buffer solution as a silanol blocker. In addition, the method was found to unequivocally assess the target analytes in the sample matrix and fulfilled the required specifications in relevance to specificity, linearity, accuracy, precision and stability of both the standard solutions and of the sample solutions. Lastly, an experimental design was designed in order to assess the robustness of the proposed assay. To this purpose, a graphical and a statistical approach were utilized and compared to identify the factors that should be strictly controlled during each execution of the method.
- Subjects :
- validation
Analyte
experimental design
Aqueous solution
Chromatography
Materials science
Physics
QC1-999
butamirate citrate
Filtration and Separation
robustness
Buffer solution
Standard solution
Analytical Chemistry
cyano column
Chemistry
Silanol
chemistry.chemical_compound
chemistry
Chromatography detector
RP-HPLC
QD1-999
Triethylamine
boric acid
Benzoic acid
Subjects
Details
- ISSN :
- 22978739
- Volume :
- 8
- Database :
- OpenAIRE
- Journal :
- Separations
- Accession number :
- edsair.doi.dedup.....5795f1d792e5e08c4ef99661015ca0ff