ABSTRACT
Objective: To establish an HPLC method to simultaneously determine 10 active ingredients in Yinzhihuang Oral Liquid (YOL) and provide scientific basis for the quality control, evaluation and standard revision of Yinzhihuang preparations. Methods: An HPLC-UV method was used with a Dikma Diamonsil C18 column (200 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-0.1% acetic acid solution with gradient elution (0-15 min, 8%-12% acetonitrile; 15-40 min, 12%-30% acetonitrile; 40-55 min, 30%-60% acetonitrile; 55-75 min, 60%-35% acetonitrile; 75-80 min, 35%-8% acetonitrile). The detection wavelength was 240 nm. The flow rate was 1.0 mL/min. The column temperature was 30 ℃. The injection volume was 20 μL. Results: Ten active ingredients (neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, geniposide, p-hydroxyphenylacetone, scutellarin, baicalin, quercetin, baicalein and wogonin) in YOL were simultaneously determined. The linearity was good (r ≥ 0. 999 0), the limit of detection and quantification were 0.003-0.018 μg/mL and 0.009-0.055 μg/mL. The average recoveries were 99.7%-102.6% with RSDs of 0.34%-6.14%. The average content of the above 10 ingredients was in turn (0.21 ± 0.09), (0.47 ± 0.01), (0.87 ± 0.06), (4.71 ± 0.27), (0.94 ± 0.20), (4.52 ± 0.80), (41.75 ± 3.53), (9.85 ± 1.67), (0.45 ± 0.09), (3.51 ± 0.89) mg/mL. The content of baicalin and geniposide was 35.44-45.82 mg/mL and 4.16-4.92 mg/mL in eight batches, respectively. All eight batches of YOL meet the requirements of the Chinese Pharmacopoeia 2015 with qualified in quality. Conclusion: The established HPLC method is simple, specific, sensitive, stable, precise, accurate, and reproducible, which can be used for quality control and evaluation of YOL.