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Stability Indicating RP-HPLC Method for Simultaneous Determination of Simvastatin and Ezetimibe from Tablet Dosage

R P Dixit¹, C R Barhate, S G Padhye

¹Departments of Pharmaceutics, Bombay College of Pharmacy, Kalina, Santacruz (E), Mumbai-400 098, India.

Indian Journal of Pharmaceutical Sciences

|September 15, 2010

Summary

A new, sensitive liquid chromatography method accurately measures ezetimibe and simvastatin in medications. This validated technique also identifies drug degradation products, ensuring pharmaceutical quality.

Keywords:

Ezetimibe reverse phase high performance liquid chromatography simvastatin stress degradation tablets

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Simvastatin and ezetimibe are commonly prescribed together for hyperlipidemia.
Accurate quantification of these drugs in pharmaceutical formulations is crucial for patient safety and efficacy.
Existing analytical methods may lack the required specificity or sensitivity for simultaneous determination and impurity profiling.

Purpose of the Study:

To develop and validate a simple, specific, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method.
To enable the simultaneous determination of ezetimibe and simvastatin in pharmaceutical dosage forms.
To assess the method's suitability for identifying degradation products.

Main Methods:

Utilized a C18 ODS Hypersil column with isocratic elution.
Employed a mobile phase of acetonitrile:phosphate buffer (pH 4.5, 0.01M) at a 65:35 v/v ratio.
Optimized UV detection at 232 nm (0-10 min) and 238 nm (10-20 min) with a flow rate of 1.0 mL/min.

Main Results:

The developed RP-HPLC method demonstrated high specificity and sensitivity.
All validation parameters met acceptable criteria, confirming method reliability.
The method was successfully applied to quantify ezetimibe and simvastatin in tablet formulations.

Conclusions:

The validated RP-HPLC method provides a robust tool for the simultaneous analysis of ezetimibe and simvastatin.
The method is suitable for routine quality control of pharmaceutical products containing these active pharmaceutical ingredients.
The assay can also be effectively used to monitor drug stability by detecting degradation products.