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.
Highlights
The present study aimed to develop and validate a simple, rapid, low cost and reproducible HPLC method for the quantitative determination of Butamirate citrate (BC) and Benzoic acid (BA) in syrup
asymmetry factor (As) rapid, reproducible and simple gradient reversed-phase high-pressure liquid chromatography (RP-HPLC) method was developed for the simultaneous quantitative determination of butamirate citrate and benzoic acid in syrup
The designed analytical procedure was validated so that its performance characteristics be rationally assessed throughout an experimental documentation, and the method itself prove to be suitable for its intended purpose
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. The number of analytical methods having been reported for the quantification of BC in pharmaceutical dosage forms, e.g., in cough preparations, is relatively limited. These methods refer to techniques such as UV-visible spectrophotometry followed by derivative transformation of the acquired spectral data [5,9]. The present study aimed to develop and validate a simple, rapid, low cost and reproducible HPLC method for the quantitative determination of BC and BA in syrup This formulation is a product of the Greek Military Pharmaceutical Laboratories in Athens, Greece. For the assessment of robustness a fractional factorial experimental design was utilized, with graphical and statistical data analysis, in an attempt to reveal the factors that “threaten” the robustness of the assay and should be carefully controlled
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