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Hydrolytic Degradation Profile and RP-HPLC Estimation of Cilostazol in Tablet Dosage Form
P K Basniwal1, P K Shrivastava, Deepti Jain
1LBS College of Pharmacy, Tilak Nagar, Jaipur-302 004, India.
Indian Journal of Pharmaceutical Sciences
|January 5, 2010
Summary
A new high-performance liquid-chromatographic method accurately analyzes cilostazol in pharmaceuticals. This validated method demonstrates precision and stability, ensuring reliable drug analysis.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Accurate quantification of cilostazol in pharmaceutical formulations is crucial for quality control.
- Existing analytical methods may lack the required selectivity, precision, or stability-indicating capabilities.
Purpose of the Study:
- To develop and validate a simple, selective, precise, and stability-indicating high-performance liquid-chromatographic (HPLC) method for cilostazol analysis.
- To assess the stability of cilostazol under various stress conditions.
Main Methods:
- HPLC analysis using a C18 column with a mobile phase of phosphate buffer:acetonitrile:methanol (20:40:40).
- Detection of cilostazol at 248 nm.
- Method validation encompassing linearity, range, accuracy, precision, and specificity.
- Stress degradation studies involving acid and alkali hydrolysis.
Main Results:
- The developed HPLC method exhibited excellent linearity (r² = 0.9998) in the concentration range of 100-3200 ng/ml.
- Cilostazol was quantified in tablet dosage forms with high accuracy (99.58-100.67%) and low standard deviation (0.4600).
- Cilostazol demonstrated stability under varying acidic and alkaline hydrolysis conditions.
Conclusions:
- The developed HPLC method is simple, selective, precise, and stability-indicating for cilostazol analysis in pharmaceutical dosage forms.
- The method's robustness and accuracy make it suitable for routine quality control and stability testing of cilostazol.
- Cilostazol exhibits good stability in acidic and alkaline environments, which is important for formulation development and storage.
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