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RP-HPLC Method for the Estimation of Dutasteride in Tablet Dosage Form
Dipti B Patel1, N J Patel, S K Patel
1S. K. Patel College of Pharmaceutical Education & Research, Department of Pharmaceutical Chemistry, Ganpat University, Kherva-382 711, India.
Indian Journal of Pharmaceutical Sciences
|June 29, 2010
Summary
A new RP-HPLC method accurately determines dutasteride in tablets. This validated technique offers a simple, sensitive, and precise approach for pharmaceutical analysis.
Area of Science:
- Pharmaceutical Analysis
- Analytical Chemistry
- Chromatography
Background:
- Dutasteride is a medication used to treat prostate conditions.
- Accurate quantification of active pharmaceutical ingredients is crucial for quality control.
Purpose of the Study:
- To develop and validate a simple, sensitive, and precise RP-HPLC method for dutasteride determination in tablet dosage forms.
Main Methods:
- RP-HPLC separation using a Phenomenex C18 column.
- Mobile phase: methanol:water (90:10 v/v) at 1 ml/min.
- Detection by photodiode array at 235 nm, concentration range 1-12 µg/ml.
Main Results:
- The developed RP-HPLC method demonstrated simplicity, sensitivity, and precision.
- The method was statistically validated for reliability.
- Successful application in determining dutasteride content in tablet formulations.
Conclusions:
- The validated RP-HPLC method is suitable for routine quality control of dutasteride in tablets.
- This analytical approach provides accurate and reliable results for pharmaceutical formulations.
