Synthesis, Characterization and Quantification of Simvastatin Metabolites and Impurities
2011
Synthesis and Analysis of Simvastatin Impurities
publication
Evidence: high
Author Information
Author(s): Bhatia Manish S., Jadhav Swapnil D., Bhatia Neela M., Choudhari Prafulla B., Ingale Kundan B.
Primary Institution: Bharati Vidyapeeth College of Pharmacy
Hypothesis
The study aims to develop a sensitive method for the simultaneous estimation of simvastatin and its impurities.
Conclusion
The developed RP-HPLC method effectively quantifies simvastatin and its impurities with high accuracy and precision.
Supporting Evidence
- The method developed for HPLC analysis complied with ICH Q2B guidelines.
- Results showed an accuracy range of 98.14% to 101.89% for all analytes.
- The method can detect impurities at concentration levels of 0.1% and less.
- Recovery studies indicated high accuracy with values between 98.21% and 100.72%.
- Precision studies showed relative standard deviation less than 2%, indicating high precision.
Takeaway
Researchers created a new way to measure simvastatin and its impurities quickly and accurately, which is important for ensuring the drug's safety.
Methodology
The study used Reverse Phase High Performance Liquid Chromatography (RP-HPLC) to analyze simvastatin and its impurities.
Digital Object Identifier (DOI)
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