Objective: To establish a method for assay of bacteriostat and taste corrector in ambroxol hydrochloride oral solution and to investigate the addition among samples in the whole country. Methods: The HPLC determination was performed on a Shiseido MGII C18(250 mm×4.6 mm, 5 μm) column; the mobile phase consisted of 0.02 mol·L-1 ammonium acetate solution (adjusted to pH 4.5 with glacial acetic acid) and methanol with a gradient elution at the flow rate of 1.0 mL·min-1; the column temperatures was 30 ℃; DAD detector was used and detection wavelength was 254 nm and 230 nm. Results: Ambroxol hydrochloride could be well separated from 4 kinds of bacteriostat and 3 kinds of taste correctors. Good linear relationships (n=6) were achieved within the mass concentration range of 0.005-0.15 mg·mL-1 with sodium benzoate (r=1.000), hydroxymethyl benzoate (r=0.999 0), hydroxyethyl benzoate (r=0.999 9), hydroxypropyl ester (r=1.000), AK sugar (r=0.999 8), saccharin sodium (r=1.000) and aspartame (r=1.000), respectively. The limits of quantitation of 4 kinds of bacteriostatfor sodium benzoate, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate and 3 kinds of flavor correctors for AK sugar, saccharin sodium and aspartame were 4.23, 0.10, 0.20, 0.21, 2.0, 4.3 and 20.1 ng, respectively. The average recoveries (n=9) were 101.2%, 102.3%, 101.0%, 101.2%, 100.8%, 100.2% and 100.7%, respectively. The samples for 22 manufacturers in the whole country were determined. For several companies, the type and quantity of bacteriostat were inconsistent with the production prescription. Conclusion: The method is accurate and specific, which can be used for the determination of bacteriostat and flavor correctors in ambroxol hydrochloride oral liquid.
WANG Xiao-liang, ZHANG Bing-hua, XI Zhi-fang, DENG Yu-long, LIANG Ya-wei
. Method establishment and investigation of bacteriostat and taste corrector assay in ambroxol hydrochloride oral solution*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(12)
: 2227
-2233
.
DOI: 10.16155/j.0254-1793.2021.12.22
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