Development and Validation of Amisulpride in Human Plasma
Author Information
Author(s): Mogili Ramakotaiah, Kanala Kanchanamala, Challa Balasekhara Reddy, Chandu Babu Rao, Bannoth Chandrasekhar Kottapalli
Primary Institution: Jawaharlal Nehru Technological University, Anantapur, Andhra Pradesh, India
Hypothesis
To develop and validate a simple, sensitive, selective, fast, rugged and reproducible analytical method for quantification of Amisulpride in human plasma samples.
Conclusion
The developed method for quantifying Amisulpride in human plasma is fast, sensitive, and reproducible, making it suitable for pharmacokinetic studies.
Supporting Evidence
- The method demonstrated intra- and inter-day precision within 0.9 to 1.7% and accuracy within 98.3 to 101.5%.
- Amisulpride was stable through multiple freeze-thaw cycles and during storage.
- The method was validated over a linear concentration range of 2.0–2500.0 ng/mL for Amisulpride.
Takeaway
Researchers created a new way to measure a medicine called Amisulpride in blood, which helps doctors understand how it works in people.
Methodology
The study used liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantify Amisulpride in human plasma, validated over a concentration range of 2.0–2500.0 ng/mL.
Limitations
The study may have limitations related to the specific population sample and the generalizability of the findings.
Participant Demographics
10 healthy human volunteers were included in the study.
Statistical Information
P-Value
p<0.05
Confidence Interval
90% CI within 80–125%
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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