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Development of a gradient HPLC method for the simultaneous determination of sotalol and sorbate in oral liquid preparations using solid core stationary phase.

Matysova L, Zahalkova O, Klovrzova S, Sklubalova Z, Solich P, Zahalka L - J Anal Methods Chem (2015)

Bottom Line: The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25°C.A sodium dihydrogen phosphate dihydrate solution (pH 2.5; 17.7 mM) was used as the mobile phase buffer.The total analysis time was 4.5 min (+2.5 min for reequilibration).

View Article: PubMed Central - PubMed

Affiliation: Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.

ABSTRACT
A selective and sensitive gradient HPLC-UV method for quantification of sotalol hydrochloride and potassium sorbate in five types of oral liquid preparations was developed and fully validated. The separation of an active substance sotalol hydrochloride, potassium sorbate (antimicrobial agent), and other substances (for taste and smell correction, etc.) was performed using an Ascentis Express C18 (100 × 4.6 mm, particles 2.7 μm) solid core HPLC column. Linear gradient elution mode with a flow rate of 1.3 mL min(-1) was used, and the injection volume was 5 µL. The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25°C. A sodium dihydrogen phosphate dihydrate solution (pH 2.5; 17.7 mM) was used as the mobile phase buffer. The total analysis time was 4.5 min (+2.5 min for reequilibration). The method was successfully employed in a stability evaluation of the developed formulations, which are now already being used in the therapy of arrhythmias in pediatric patients; the method is also suitable for general quality control, that is, not only just for extemporaneous preparations containing the mentioned substances.

No MeSH data available.


Related in: MedlinePlus

Chromatograms of the standard solution (SOT 0.2 mg mL−1, SORB 0.04 mg mL−1, and EP 0.08 mg mL−1), sample solution (1.000 mL of pharmaceutical preparation and 1.000 mL of stock solution of internal standard EP diluted to 25.00 mL), and blank solution (1.000 mL of placebo diluted to 25.00 mL); injection volume 5 μL; mobile phase flow 1.3 mL min−1; linear gradient (ACN: 10% to 60% in 4 minutes); UV/Vis detector wavelength 237 nm; column oven 25°C.
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fig2: Chromatograms of the standard solution (SOT 0.2 mg mL−1, SORB 0.04 mg mL−1, and EP 0.08 mg mL−1), sample solution (1.000 mL of pharmaceutical preparation and 1.000 mL of stock solution of internal standard EP diluted to 25.00 mL), and blank solution (1.000 mL of placebo diluted to 25.00 mL); injection volume 5 μL; mobile phase flow 1.3 mL min−1; linear gradient (ACN: 10% to 60% in 4 minutes); UV/Vis detector wavelength 237 nm; column oven 25°C.

Mentions: The selectivity was determined by comparing the chromatograms of sample solutions, standard solution, and blank solutions. Figure 2 shows that sotalol hydrochloride (i.e., the active substance), potassium sorbate (i.e., antimicrobial agent), and ethylparaben (i.e., internal standard) are all completely separated from each other and from the saccharine peak both in the standard solution and in the sample solution. No interference was observed.


Development of a gradient HPLC method for the simultaneous determination of sotalol and sorbate in oral liquid preparations using solid core stationary phase.

Matysova L, Zahalkova O, Klovrzova S, Sklubalova Z, Solich P, Zahalka L - J Anal Methods Chem (2015)

Chromatograms of the standard solution (SOT 0.2 mg mL−1, SORB 0.04 mg mL−1, and EP 0.08 mg mL−1), sample solution (1.000 mL of pharmaceutical preparation and 1.000 mL of stock solution of internal standard EP diluted to 25.00 mL), and blank solution (1.000 mL of placebo diluted to 25.00 mL); injection volume 5 μL; mobile phase flow 1.3 mL min−1; linear gradient (ACN: 10% to 60% in 4 minutes); UV/Vis detector wavelength 237 nm; column oven 25°C.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4388021&req=5

fig2: Chromatograms of the standard solution (SOT 0.2 mg mL−1, SORB 0.04 mg mL−1, and EP 0.08 mg mL−1), sample solution (1.000 mL of pharmaceutical preparation and 1.000 mL of stock solution of internal standard EP diluted to 25.00 mL), and blank solution (1.000 mL of placebo diluted to 25.00 mL); injection volume 5 μL; mobile phase flow 1.3 mL min−1; linear gradient (ACN: 10% to 60% in 4 minutes); UV/Vis detector wavelength 237 nm; column oven 25°C.
Mentions: The selectivity was determined by comparing the chromatograms of sample solutions, standard solution, and blank solutions. Figure 2 shows that sotalol hydrochloride (i.e., the active substance), potassium sorbate (i.e., antimicrobial agent), and ethylparaben (i.e., internal standard) are all completely separated from each other and from the saccharine peak both in the standard solution and in the sample solution. No interference was observed.

Bottom Line: The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25°C.A sodium dihydrogen phosphate dihydrate solution (pH 2.5; 17.7 mM) was used as the mobile phase buffer.The total analysis time was 4.5 min (+2.5 min for reequilibration).

View Article: PubMed Central - PubMed

Affiliation: Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Kralove, Charles University in Prague, 500 05 Hradec Kralove, Czech Republic.

ABSTRACT
A selective and sensitive gradient HPLC-UV method for quantification of sotalol hydrochloride and potassium sorbate in five types of oral liquid preparations was developed and fully validated. The separation of an active substance sotalol hydrochloride, potassium sorbate (antimicrobial agent), and other substances (for taste and smell correction, etc.) was performed using an Ascentis Express C18 (100 × 4.6 mm, particles 2.7 μm) solid core HPLC column. Linear gradient elution mode with a flow rate of 1.3 mL min(-1) was used, and the injection volume was 5 µL. The UV/Vis absorbance detector was set to a wavelength of 237 nm, and the column oven was conditioned at 25°C. A sodium dihydrogen phosphate dihydrate solution (pH 2.5; 17.7 mM) was used as the mobile phase buffer. The total analysis time was 4.5 min (+2.5 min for reequilibration). The method was successfully employed in a stability evaluation of the developed formulations, which are now already being used in the therapy of arrhythmias in pediatric patients; the method is also suitable for general quality control, that is, not only just for extemporaneous preparations containing the mentioned substances.

No MeSH data available.


Related in: MedlinePlus