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Related Experiment Videos

Impurity profile study of loratadine.

K V S R Krishna Reddy1, J Moses Babu, Y Ravindra Kumar

  • 1Department of Analytical Research, Discovery Research Division, Dr Reddy's Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad 500 050, India.

Journal of Pharmaceutical and Biomedical Analysis
|July 11, 2003
PubMed
Summary

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Three unknown impurities in loratadine bulk drug were identified using high-performance liquid chromatography (HPLC). Their structures were characterized, and their synthesis pathways were discussed.

Area of Science:

  • Analytical Chemistry
  • Organic Chemistry
  • Pharmaceutical Sciences

Background:

  • Loratadine is a widely used antihistamine.
  • Ensuring the purity of bulk drug substances is critical for pharmaceutical safety and efficacy.
  • Identification and characterization of unknown impurities are essential for quality control.

Purpose of the Study:

  • To detect and identify unknown impurities in loratadine bulk drug.
  • To isolate and characterize the structures of these impurities.
  • To discuss the synthesis of the identified impurities.

Main Methods:

  • Simple isocratic reversed-phase high-performance liquid chromatography (HPLC) for impurity detection.
  • Reversed-phase preparative HPLC for isolation of impurities.

Related Experiment Videos

  • Spectroscopic techniques including Infrared (IR), Nuclear Magnetic Resonance (NMR), and Mass Spectrometry (MS) for structural characterization.

    • Main Results:

    • Three unknown impurities were detected in loratadine bulk drug at levels below 0.1%.
    • The impurities were isolated and structurally elucidated using spectral data.
    • The characterized impurities are 11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta(1,2-b)-pyridine (I), 8-bromo-11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (II), and 8-chloro-11-(N-carboethoxy-4-piperidylidene)-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (III).

    Conclusions:

    • The study successfully identified and characterized three novel impurities in loratadine.
    • The synthetic routes for these impurities were explored, contributing to a better understanding of loratadine degradation and synthesis.
    • This work provides valuable data for the quality control and regulatory assessment of loratadine bulk drug.