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Validation of an HPLC-MS method for rociverine tablet dissolution analysis
Ela Hoti1, Roberta Censi, Massimo Ricciutelli
1University of Tirana, Department of Pharmacy, Rr Dibres, Albania.
A new HPLC-MS method was developed and validated to measure rociverine dissolution from sugar-coated tablets. This validated analytical method ensures quality control for rociverine tablets, showing 95% drug dissolution within 30 minutes.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Rociverine sugar-coated tablets require a validated dissolution method for quality control.
- No official dissolution method is currently available for rociverine tablets.
Purpose of the Study:
- To develop and validate a high-performance liquid chromatography-mass spectrometry (HPLC-MS) method for assessing rociverine dissolution.
- To determine the dissolution rate of industrially produced rociverine tablets.
Main Methods:
- Development of a reverse-phase HPLC-MS analytical method for rociverine quantification.
- Dissolution testing conducted under sink conditions (0.01 N HCl, 50 rpm paddle speed, 1000 ml volume).
- Method validation including specificity, linearity, precision, accuracy, and robustness.
Main Results:
- The developed HPLC-MS method accurately quantifies rociverine in solution.
- Dissolution tests showed 95% rociverine dissolved within 30 minutes and complete dissolution within 60 minutes.
- The method proved adequate for quality control of rociverine tablets.
Conclusions:
- A validated HPLC-MS method is suitable for determining the dissolution behavior of rociverine sugar-coated tablets.
- The established method ensures reliable quality control for rociverine tablet manufacturing.
- The dissolution profile indicates efficient drug release characteristics.
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