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Related Experiment Videos

Stability-indicating assay for tolmetin sodium in solid dosage forms

C A Janicki, K F Daly

    Journal of Pharmaceutical Sciences
    |February 1, 1980
    PubMed
    Summary

    A new spectrophotometric assay accurately determines tolmetin sodium in solid dosage forms. This method effectively separates the drug from excipients and degradation products, ensuring reliable quality control.

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    Area of Science:

    • Analytical Chemistry
    • Pharmaceutical Analysis
    • Spectrophotometry

    Background:

    • Accurate quantification of active pharmaceutical ingredients (APIs) is crucial for drug safety and efficacy.
    • Existing methods for tolmetin sodium determination may face challenges with complex pharmaceutical matrices.
    • Stability assessment of aged dosage forms requires reliable analytical techniques.

    Purpose of the Study:

    • To develop and validate a spectrophotometric assay for the quantitative determination of tolmetin sodium.
    • To establish a method for separating tolmetin sodium from common pharmaceutical excipients and potential degradation products.
    • To provide qualitative methods for monitoring the stability of tolmetin sodium in aged pharmaceutical formulations.

    Main Methods:

    • Development of a spectrophotometric assay for tolmetin sodium quantification.
    • Implementation of separation techniques to isolate tolmetin sodium from interfering substances.
    • Validation of the assay using recovery, precision, and accuracy studies.
    • Application of two thin-layer chromatography (TLC) methods for qualitative stability assessment.

    Main Results:

    • The developed spectrophotometric assay demonstrated reliable recovery, precision, and accuracy for tolmetin sodium.
    • Effective separation of tolmetin sodium from common pharmaceutical excipients was achieved.
    • Identification of probable degradation products was facilitated by the separation method.
    • Two TLC methods were successfully applied to qualitatively monitor the stability of aged dosage forms.

    Conclusions:

    • A robust spectrophotometric assay is suitable for the routine determination of tolmetin sodium in solid dosage forms.
    • The described separation strategy enhances the specificity of the assay.
    • The complementary TLC methods provide valuable tools for pharmaceutical stability studies of tolmetin sodium.

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