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Dissolution test method for rifampicin-isoniazid fixed dose formulations
K C Jindal1, R S Chaudhary, A K Singla
1Lupin Laboratories Limited, M.I.D.C., Aurangabad, India.
Journal of Pharmaceutical and Biomedical Analysis
|April 1, 1994
Summary
Sodium lauryl sulphate solution is a suitable dissolution medium for rifampicin-isoniazid formulations. Hydrochloric acid caused significant degradation, highlighting the importance of selecting appropriate dissolution media for drug analysis.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
Background:
- Rifampicin and isoniazid are crucial drugs for tuberculosis treatment.
- Accurate dissolution testing is vital for ensuring drug efficacy and quality.
Purpose of the Study:
- To evaluate the suitability of different dissolution media for a rifampicin-isoniazid combination.
- To assess the stability of rifampicin and isoniazid in various dissolution media.
Main Methods:
- Dissolution testing using 0.1 N hydrochloric acid and 0.4% sodium lauryl sulphate solutions.
- Reversed-phase liquid chromatography with octadecylsilica column for analyzing rifampicin, isoniazid, and degradation products.
- Detection at 254 nm using a methanol-disodium hydrogen phosphate mobile phase.
Main Results:
- 0.4% sodium lauryl sulphate solution proved suitable as a dissolution medium.
- Significant degradation (10-23%) of rifampicin and isoniazid was observed in 0.1 N hydrochloric acid.
- The chromatographic method effectively separated the drugs from their degradation components.
Conclusions:
- 0.4% sodium lauryl sulphate is recommended for dissolution studies of rifampicin-isoniazid combinations.
- 0.1 N hydrochloric acid is not suitable due to drug degradation, impacting dissolution profile accuracy.