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Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
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Characterization, thermal stability studies, and analytical method development of Paromomycin for formulation

Wahid Khan1, Neeraj Kumar

  • 1Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Nagar, India.

Drug Testing and Analysis
|June 24, 2011
PubMed
Summary

Paromomycin (PM) is stable up to 120°C, but degrades at 130°C, losing biological activity. A new RP-HPLC method accurately quantifies PM in pharmaceutical formulations.

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Microbiology

Background:

  • Paromomycin (PM), an aminoglycoside antibiotic, lacks comprehensive pharmaceutical formulation data despite its approval for visceral leishmaniasis.
  • Understanding PM's thermal stability is crucial for developing stable pharmaceutical formulations.

Purpose of the Study:

  • To determine the thermal stability of Paromomycin (PM).
  • To develop a novel analytical method for quantifying PM in pharmaceutical formulations.

Main Methods:

  • Thermoanalytical techniques (DSC, TGA, HSM) and FTIR spectroscopy were used to assess PM stability.
  • PM samples were heated at various temperatures (100-130°C) for 24 hours.
  • Biological activity was evaluated using microbiological assays.
  • A sensitive RP-HPLC method with pre-column derivatization was developed for PM quantification.

Main Results:

  • Paromomycin demonstrated stability when heated up to 120°C for 24 hours.
  • At 130°C, PM exhibited degradation, with a significant loss of biological activity (approximately 30%).
  • The developed RP-HPLC method accurately quantified PM in parenteral dosage forms with high precision (<2% RSD).

Conclusions:

  • Paromomycin is thermally stable at temperatures up to 120°C but susceptible to degradation at 130°C.
  • The newly developed RP-HPLC method is suitable for the sensitive, accurate, and precise quantification of PM.
  • These findings are essential for the successful development of stable Paromomycin pharmaceutical formulations.