Uniform Sampling Table Method and its Applications II--Evaluating the Uniform Sampling by Experiment.

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry
• Quality Control

Background:

• Traditional sampling methods may lack efficiency and uniformity.
• Accurate and reproducible drug analysis is crucial for quality control.

Purpose of the Study:

• To evaluate a new uniform sampling method for drug analysis.
• To assess its convenience, uniformity, accuracy, and reproducibility compared to standard methods.

Main Methods:

• Evaluation using items like operational convenience and site distribution uniformity.
• Indexes included operational complexity and relative accuracy/deviation of pill weight.
• Gray correlation analysis was used for comprehensive evaluation against a standard method.
• Experiments conducted on three drug types using four sampling methods.

Main Results:

• Uniform sampling method achieved 100% convenience and infinite odds ratio for site occupation.
• Relative accuracy ranged from 99.50-99.89% with reproducibility RSD of 0.45-0.89%.
• Weighted incidence degree surpassed the standard method, indicating superior performance.

Conclusions:

• The uniform sampling method is easy to operate with uniform sample distribution.
• It exhibits excellent accuracy and reproducibility for drug analysis.
• This method is recommended for practical implementation in pharmaceutical quality control.