Analysis of Shenhuang Capsule using HPLC: Method Development, Validation, and Application

Objective: Shenhuang (SH) capsule is a traditional Chinese medicine compound preparation containing rhubarb, coptis, scutellaria, salvia and Pueraria, used for diabetic nephropathy studied by our research group in the early stage. This study aims to develop the method of qualitative identification and content determination of the main active ingredients of SH capsules so as to establish the quality standard. Methods: HPLC method was used to determine the contents of rhein, Pueraria, and tanshinone in SH capsules. The determination method of SH capsules was established through the determination of specificity, regression equation, precision, repeatability, and recovery. The general quality standard of SH capsules was established by measuring water content, disintegration time, and microorganism. The contents of rhein, puerarin, and tanshinone IIA in SH capsules were determined by HPLC. Results: The precision was 1.10–3.00% and the reproducibility and recovery rates were 95.0– 105.7%. The moisture determination, disintegration time, and microorganism examination of SH capsule were all in line with the standard. Conclusion: The stable, feasible, simple, and reliable content determination method was established through the content determination of SH capsules and the general quality standard test.