Establishment of determination of tetrodotoxin sustained-release microspheres

VernacularTitle:河豚毒素缓释微球含量测定方法的建立
Author: Qi WANG ¹ ; Guangzhao LU ¹ ; Yuan LI ¹ ; Li FAN ¹ ; He ZHANG ¹ ; Ying LU ¹
Author Information

1. Department of pharmaceutics, School of Pharmacy, Naval Medical University, Shanghai 200433, China.
Keywords: Tetrodotoxin; HPLC; sustained-release microspheres; sodium heptane sulfonate
From: Journal of Pharmaceutical Practice 2023;41(3):182-186
CountryChina
Language:Chinese
Abstract: Objective To establish a detection method for the determination of tetrodotoxin (TTX) in sustained-release microspheres. Methods The HPLC separation of tetrodotoxin was performed on an Agilent ZORBAX SB-C₁₈ column (4.6mm×150mm,5 μm) with acetonitrile, 8mmol/L sodium heptane sulfonate containing 0.005% TFA (5:95) (pH 4.0) as the mobile phase. The flow rate was 1.0 ml/min. The UV detection wavelength was 200 nm and the column temperature was 30 °C. Results The method had good specificity and linearity of TTX in the concentration range of 1−20 μg/ml. The intra-day precision, inter-day precision, stability and repeatability of the method were good, and the average recoveries were found between 98.0% and 102.0%. Conclusion This study established an HPLC method which was suitable for the determination of tetrodotoxin sustained-release microspheres. The method is accurate and reliable within the applicable range, with strong specificity, which could lead to quantitative detection.