Use of an Uncertainty Profile to Validate High-Performance Liquid Chromatography (HPLC) for the Simultaneous Determination of Statins in Synthetic Pharmaceutical Products

Abstract

Here is reported a full validation of a high-performance liquid chromatography (HPLC) method for the determination of statins in a pharmaceutical product using the uncertainty profile. In addition, the uncertainty estimates based on the β-content, γ-confidence tolerance intervals are compared to those using the β-expectation tolerance interval via a graphical comparison. The results are useful in elucidating the applicability and flexibility of the uncertainty profile, which allows the analyst to choose the desired proportion of the results with a well-determined uncertainty. This approach allowed the determination of the validity of the statin assays. Four of the five statin dosages were shown to be accurate by demonstrating that more than 90% of the outcomes were compliant; however, rosuvastatin’s dosage was valid only by ensuring an 80% compliance rate. The uncertainty profile is a widely applicable strategy that may be used to evaluate analytical methods and compute the uncertainty in order to confirm suitability for use while providing reliable results.

Keywords:

• High-performance liquid chromatography (HPLC)
• measurement uncertainty
• pharmaceutical matrix
• statins
• uncertainty profile

Acknowledgement

The authors are grateful to the anonymous reviewers for comments that led to significant improvement of this article.