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[Determination of five components in compound hypotensive tablet by HPLC]
1Beijing Institute for Drug Control, Beijing 100035, China. chebaoquan89@sina.com
Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|November 26, 2004
Summary
A new analytical method accurately determines five active ingredients in compound hypotensive tablets. This validated method ensures quality control for pharmaceutical formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Context:
- Compound hypotensive tablets contain multiple active pharmaceutical ingredients.
- Accurate quantification of these components is crucial for therapeutic efficacy and patient safety.
Purpose:
- To develop and validate a robust analytical method for determining five key components in compound hypotensive tablets.
- Establish a reliable quality control procedure for this pharmaceutical formulation.
Summary:
- A high-performance liquid chromatography (HPLC) method was established using a CN column.
- Optimized mobile phases (acetonitrile-0.1 mol L(-1) sodium heptasulfonate solution in ratios 7:3 and 5:5) and specific detection wavelengths (267 nm, 310 nm, 360 nm) were employed.
- The method demonstrated satisfactory linearity, recovery, and stability for reserpine, chlordiazepoxide, hydrochlorothiazide, dihydralazine sulfate, and triamterene.
Impact:
- Provides an accurate and credible quality control method for compound hypotensive tablets.
- Facilitates consistent manufacturing and quality assurance of antihypertensive medications.
- Supports regulatory compliance and ensures the reliability of pharmaceutical products.