Method for Testing Ranitidine in Liquid Form
Author Information
Author(s): Nitish Sharma, Surendra Singh Rao, Namala Durga Atchuta Kumar, Pingili Sunil Reddy, Malleswara Reddy Annarapu
Primary Institution: Dr. Reddy’s Laboratories Ltd.
Hypothesis
Can a stability-indicating HPLC method be developed for the determination of ranitidine and its impurities in liquid oral dosage forms?
Conclusion
The developed HPLC method for ranitidine is precise, accurate, and robust, making it suitable for routine analysis.
Supporting Evidence
- The method was validated for specificity, precision, accuracy, and robustness.
- Ranitidine was found to degrade significantly under certain stress conditions.
- The method allows for the detection of ranitidine impurities in pharmaceutical preparations.
Takeaway
Scientists created a new way to test a medicine called ranitidine to make sure it’s safe and has no bad stuff in it.
Methodology
A gradient reverse phase high-performance liquid chromatographic (HPLC) method was developed and validated according to ICH guidelines.
Limitations
The method may not account for all possible impurities or degradation products not tested.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website