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Method development and validation for the HPLC assay (potency and related substances) for 20 mg paroxetine tablets
J Lambropoulos1, G A Spanos, N V Lazaridis
1Analytical Method Development and Validation, AAI, Inc., Wilmington, NC 28405, USA.
Journal of Pharmaceutical and Biomedical Analysis
|March 4, 2000
Summary
A validated stability-indicating assay using high-performance liquid chromatography (HPLC) was developed to measure paroxetine potency and related substances in 20 mg tablets. This method ensures accurate drug quality assessment for paroxetine hydrochloride formulations.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
- Chromatography
Background:
- Ensuring the quality and stability of pharmaceutical products is crucial for patient safety.
- Paroxetine hydrochloride is a widely used antidepressant medication.
- Stability-indicating assays are essential for monitoring drug degradation and ensuring product shelf-life.
Purpose of the Study:
- To develop and validate a stability-indicating assay for paroxetine.
- To quantify paroxetine potency and detect related substances in paroxetine hydrochloride tablets.
- To establish a reliable analytical method for pharmaceutical quality control.
Main Methods:
- Reversed-phase high-performance liquid chromatography (HPLC) was employed.
- A C18 column was used with isocratic elution.
- Mobile phase consisted of a buffer and acetonitrile (ACN) mixture, with UV detection at 235 nm.
Main Results:
- A stability-indicating HPLC method was successfully developed and validated.
- The method accurately determined paroxetine potency and quantified related substances.
- The assay demonstrated suitability for analyzing paroxetine hydrochloride 20 mg tablets.
Conclusions:
- The developed HPLC method is suitable for stability testing of paroxetine hydrochloride tablets.
- This validated assay provides a reliable tool for pharmaceutical quality control.
- The method ensures the potency and purity of paroxetine formulations over time.