Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Challenges in the analytical method development and validation for an unstable active pharmaceutical ingredient.

Peter Sajonz1, Yan Wu, Theresa K Natishan

  • 1Merck Research Laboratories, Merck & Co., Inc., P.O. Box 2000, RY801-A101, Rahway, NJ 07065, USA.

Journal of Chromatographic Science
|April 20, 2006
PubMed
Summary

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Limonoids from the stems of Toona ciliata var. henryi (Meliaceae).

Phytochemistry·2011
Same author

Preparation of thermoresponsive and pH-sensitivity polymer magnetic hydrogel nanospheres as anticancer drug carriers.

Colloids and surfaces. B, Biointerfaces·2011
Same author

Characterization and anti-tumor activity of chemical conjugation of doxorubicin in polymeric micelles (DOX-P) in vitro.

Cancer letters·2011
Same author

Acute probiotic ingestion reduces gastrointestinal oxalate absorption in healthy subjects.

Urological research·2011
Same author

A lipoxin A4 analog ameliorates blood-brain barrier dysfunction and reduces MMP-9 expression in a rat model of focal cerebral ischemia-reperfusion injury.

Journal of molecular neuroscience : MN·2011
Same author

Aspirin-triggered lipoxin A4 attenuates LPS-induced pro-inflammatory responses by inhibiting activation of NF-κB and MAPKs in BV-2 microglial cells.

Journal of neuroinflammation·2011

A new high-performance liquid chromatography (HPLC) method accurately profiles impurities in the antibiotic ertapenem. This validated method ensures drug quality by detecting various impurities and degradation products.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Ertapenem is a crucial antibiotic requiring rigorous quality control.
  • Analyzing unstable active pharmaceutical ingredients (APIs) presents significant challenges.
  • Accurate impurity profiling is essential for pharmaceutical product safety and efficacy.

Purpose of the Study:

  • To develop and validate a sensitive high-performance liquid chromatography (HPLC) method for ertapenem impurity profiling.
  • To address the analytical challenges associated with unstable APIs like ertapenem.
  • To ensure the specificity and reliability of the impurity detection method.

Main Methods:

  • Utilized an Inertsil phenyl column with gradient elution (aqueous sodium phosphate buffer pH 8 and acetonitrile).
  • Employed ambient temperature and validated linearity, precision, ruggedness, LOQ, and LOD.

Related Experiment Videos

  • Assessed specificity using crude samples, stressed solutions (thermal, light, acid, base, oxidative), and photodiode array detection.

    • Main Results:

    • The developed HPLC method demonstrated satisfactory linearity, precision, ruggedness, LOQ, and LOD.
    • The method proved specific, effectively separating ertapenem from in-process impurities and degradation products.
    • Photodiode array detection confirmed no coelution of impurities with different UV spectra.

    Conclusions:

    • A robust and validated HPLC method for ertapenem impurity profiling has been established.
    • The method successfully addresses the challenges of analyzing unstable ertapenem and its impurities.
    • Relative response factors for key impurities/degradates were determined, enhancing quantitative accuracy.