Simultaneous Quantification of 13 Compounds in Guanxin Shutong Capsule by HPLC Method

Area of Science:

• Pharmacology and Pharmaceutical Analysis
• Chromatographic Techniques

Background:

• Guanxin Shutong (GXST) capsule is a common treatment for coronary heart disease.
• Current quality control standards for GXST capsules are insufficient to ensure product quality.

Purpose of the Study:

• To develop and validate a new high-performance liquid chromatographic (HPLC) method for the simultaneous determination of 13 key compounds in GXST capsules.
• To establish a reliable analytical method for improving the quality control of GXST capsules.

Main Methods:

• Development of a simultaneous determination method using a C18 column with gradient elution (0.05% phosphoric acid and acetonitrile).
• Quantification of 13 compounds: gallic acid, danshensu, protocatechuic acid, procatechuic aldehyde, ellagic acid, rosmarinic acid, salvianolic acid A and B, eugenol, dihydrotanshinone I, cryptotanshinone, tanshinone I, and tanshinone IIA.
• Validation of the method for linearity, intra-day and inter-day variability, and recovery.

Main Results:

• The HPLC method achieved successful separation and quantification of all 13 target compounds.
• Excellent linearity was observed (r > 0.9991) across a wide concentration range.
• The method demonstrated high precision (variability < 2.86%) and accuracy (recoveries 95.24-104.75%).

Conclusions:

• The developed HPLC method is reliable, accurate, and suitable for the simultaneous quantification of 13 compounds in GXST capsules.
• This validated method provides a robust tool for enhancing the quality control of GXST capsules.
• The improved quality control is expected to contribute to the consistent therapeutic efficacy of GXST capsules in treating coronary heart disease.