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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

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Stability-indicating Method for the Estimation of Riluzole in Tablets.

T Neeha1, P Bhargavi, A Aruna Jyothi

  • 1Department of Pharmaceutical Analysis, K. V. S. R. Siddhartha College of Pharmaceutical Sciences, Pinnamaneni Polyclinic Road, Siddhartha Nagar, Benz Circle, Vijayawada-520 010, India.

Indian Journal of Pharmaceutical Sciences
|October 2, 2013
PubMed
Summary

A new stability-indicating method accurately measures riluzole in bulk and tablets. This high-pressure liquid chromatography method is validated and effective for quality control of riluzole formulations.

Keywords:
Riluzoleforced degradationreverse phase liquid chromatographyvalidation

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Riluzole is a medication used to treat amyotrophic lateral sclerosis (ALS).
  • Ensuring the stability and accurate quantification of riluzole in pharmaceutical formulations is crucial for patient safety and therapeutic efficacy.

Purpose of the Study:

  • To develop and validate a stability-indicating analytical method for the estimation of riluzole.
  • To assess the degradation behavior of riluzole under various stress conditions.

Main Methods:

  • A stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed using a photodiode array (PDA) detector.
  • Riluzole samples (bulk and tablet dosage forms) were subjected to stress conditions including light, heat, humidity, acid/base hydrolysis, and oxidation.
  • The developed method was validated according to International Conference on Harmonization (ICH) guidelines.

Main Results:

  • The method demonstrated good resolution between riluzole and its degradation products.
  • Degradation of riluzole was observed under acidic, basic, oxidative, and thermal stress conditions.
  • The method showed linearity in the range of 10-50 μg/ml with a correlation coefficient of 0.9998, indicating high precision and accuracy (assay 100.92%, recovery 101.10%).

Conclusions:

  • The developed RP-HPLC-PDA method is stability-indicating, specific, and suitable for the quantitative analysis of riluzole in bulk and pharmaceutical formulations.
  • The method provides a reliable tool for quality control and stability assessment of riluzole products.