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Sreenivas Pippalla1, Arjuna Rao Nekkalapudi2, Venugopal Reddy Komreddy3

  • 1Sikkim Professional University, Gangtok, Sikkim, India.

Biomedical Chromatography : BMC
|July 15, 2024
PubMed
Summary
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A new ultra-performance liquid chromatography (UPLC) method accurately quantifies promethazine (active ingredient) and its preservatives in oral solutions. This validated method ensures the quality and stability of pharmaceutical liquid formulations.

Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis
  • Chromatography

Context:

  • Pharmaceutical liquid oral formulations require accurate quantification of active ingredients and preservatives for quality control.
  • Existing methods may not efficiently analyze multiple components simultaneously, necessitating the development of integrated analytical techniques.
  • Promethazine hydrochloride and dextromethorphan hydrobromide are common active ingredients in oral solutions, often formulated with preservatives like methylparaben, propylparaben, and sodium benzoate.

Purpose:

  • To develop and validate a single, sensitive, and stability-indicating ultra-performance liquid chromatography (UPLC) method for the simultaneous estimation of promethazine hydrochloride, methylparaben, propylparaben, and sodium benzoate in a pharmaceutical liquid oral formulation.
  • To establish a robust analytical procedure that meets International Conference on Harmonization (ICH) and United States Pharmacopeia (USP) guidelines for method validation.
Keywords:
UPLCassaymethylparabenpromethazine HClpromethazine HCl and dextromethorphan HBr oral solutionpropylparabensodium benzoate

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Summary:

  • A reverse-phase UPLC method was developed using a C18 column with a mobile phase consisting of 0.1% perchloric acid and methanol.
  • The method demonstrated excellent linearity (correlation coefficient of 1.00) and accuracy (recoveries ranging from 99.0% to 100.2%) for promethazine hydrochloride, methylparaben, propylparaben, and sodium benzoate.
  • The developed UPLC method is specific, sensitive, efficient, rugged, and stable, suitable for quantifying active ingredients and preservatives in oral solutions.

Impact:

  • Provides a validated, single-step analytical method for comprehensive quality control of promethazine-containing oral solutions.
  • Enhances the efficiency and reliability of pharmaceutical analysis, ensuring product safety and efficacy.
  • Contributes to the standardization of analytical procedures in pharmaceutical development and manufacturing.