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Stability-indicating assay for hydrochlorothiazide

S L Daniels, A J Vanderwielen

Journal of Pharmaceutical Sciences

|February 1, 1981

Summary

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A new stability-indicating method accurately quantifies hydrochlorothiazide in tablets and bulk forms. This validated assay also effectively detects impurities, ensuring drug quality and safety.

Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Hydrochlorothiazide is a widely used diuretic.
Accurate quantification and impurity profiling are crucial for pharmaceutical quality control.

Purpose of the Study:

To develop and validate a stability-indicating method for hydrochlorothiazide.
To ensure accurate determination of hydrochlorothiazide in various pharmaceutical forms and detect impurities.

Main Methods:

High-performance liquid chromatography (HPLC) using a C18 column.
Methanol extraction and an aqueous mobile phase with acetic acid buffer (pH 4.5).
Sulfadiazine as an internal standard.

Main Results:

The method demonstrated accuracy for multiple tablet and bulk drug lots from different suppliers.

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The assay achieved a relative standard deviation of approximately 1%.

The method is suitable for detecting impurities in the range of 0.1% to 5%.

Conclusions:

A robust and accurate stability-indicating HPLC method for hydrochlorothiazide has been established.
The method is applicable for routine quality control of hydrochlorothiazide formulations and bulk drug.
The assay serves as a reliable tool for impurity testing.