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Semiautomated method for analysis of nitroglycerin in sublingual tablets: collaborative study
Journal - Association of Official Analytical Chemists
|July 1, 1980
Summary
A new semiautomated method for nitroglycerin tablet content uniformity testing was developed. This validated assay method is accurate, precise, and sensitive enough for individual tablet analysis.
Area of Science:
- Pharmaceutical Analysis
- Analytical Chemistry
Background:
- Content uniformity testing is crucial for ensuring accurate nitroglycerin dosage in tablets.
- The current United States Pharmacopeia (USP) XX method for nitroglycerin content uniformity is manual.
Purpose of the Study:
- To develop and validate a semiautomated method for nitroglycerin content uniformity testing.
- To provide a more efficient and precise alternative to the existing USP XX method.
Main Methods:
- Semiautomated assay involving alkaline hydrolysis of nitroglycerin to nitrite.
- Diazotization of procaine followed by coupling with the Bratton-Marshall reagent.
- Spectrophotometric measurement of color absorbance at 550 nm.
Main Results:
- The semiautomated method demonstrated agreement with the USP composite assay method.
- Coefficients of variation ranged from 0.20% to 0.70%, indicating high precision.
- The method is sensitive for quantifying as little as 0.15 mg of nitroglycerin per tablet.
Conclusions:
- The developed semiautomated method is suitable for content uniformity testing of nitroglycerin tablets.
- The method offers improved efficiency and precision compared to the manual USP XX method.
- This validated method has been officially adopted for pharmaceutical analysis.