The Analysis of Pravastatin in Human Plasma

Chemical structure of Pravastatin. Source: https://en.wikipedia.org/wiki/Pravastatin

What is Pravastatin?

“Pravastatin belongs to a group of medicines called statins, it is used to lower cholesterol if you’ve been diagnosed with high blood cholesterol, it is also taken to prevent heart disease including heart attacks and strokes” (1)

1 in 1000 people taking pravastatin may have serious side effects such as: muscle pain, tenderness, weakness or cramps, severe stomach pain. In rare cases its possible to have a serious allergic reaction (anaphylaxis).

Method:

The first objective of this project was to validate a method for the quantitation of pravastatin residues in human plasma by LCMS analysis.  The second objective was to validate a method for the quantitation of pravastatin lactone in human plasma by LCMS analysis.

The LLOQ and ULOQ were established for the method as 1ng/ml and 100ng/ml respectively for Pravastatin and defined as the lowest and highest validated concentration that meet all acceptance criteria. Accuracy and precision were established at the LLOQ.
.The Limit of Detection for Pravastatin was calculated as 0.885654ng/ml in human plasma.

It was not possible to validate the method for Pravastatin Lactone as it was too unstable, however the Limit of Detection was established to be 11.81485ng/ml in human plasma.

This project took seven years from initial discussion to receipt of samples, so patience is sometimes required!

References.

(1) Pravastatin: a medicine used to lower cholesterol [Internet]. nhs.uk. 2020 [cited 13 November 2020]. Available from: https://www.nhs.uk/medicines/pravastatin/