New Method for Testing Loratadine and Its Impurities
Author Information
Author(s): Ramulu Gajjela, Ravindra Kumar Yalavarthi, Vyas Krishnamurthy, Suryanarayana Mulukutla V., Mukkanti Khagga
Primary Institution: Dr. Reddy’s Laboratories Ltd.
Hypothesis
An improved analytical method for the determination of impurities and degradation products in Loratadine drug substance will enhance accuracy and reliability.
Conclusion
The new HPLC method is selective, sensitive, precise, and accurate for determining impurities and degradation products in Loratadine.
Supporting Evidence
- The method was validated according to ICH guidelines.
- Recovery rates for impurities were found to be between 85-115%.
- The method demonstrated linearity over a specified range for all impurities.
Takeaway
Scientists created a better way to test a medicine called Loratadine to make sure it’s safe and has no bad stuff in it.
Methodology
The method involved gradient, reversed-phase liquid chromatography (RP-LC) with UV detection at 220 nm to separate Loratadine from its impurities.
Digital Object Identifier (DOI)
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