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Stability indicating method for determination of nortriptyline hydrochloride using 3-methyl-2-benzothiazolinone
N A El Ragehy1, S S Abbas, S Z El-Khateeb
1Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini, St. 11562 Cairo, Egypt. n.a.ragehy@mailcity.com
Journal of Pharmaceutical and Biomedical Analysis
|March 29, 2001
Summary
A new spectrophotometric method accurately determines nortriptyline hydrochloride using 3-Methyl-2-benzothiazolinone hydrazone (MBTH) and cerium(IV) ammonium sulphate. This method is effective for drug analysis, even with degradates present.
Area of Science:
- Analytical Chemistry
- Pharmaceutical Analysis
Background:
- Accurate quantification of nortriptyline hydrochloride is crucial for pharmaceutical quality control.
- Existing methods may not adequately address the presence of drug degradates.
Purpose of the Study:
- To develop and validate a novel spectrophotometric method for determining nortriptyline hydrochloride.
- To assess the method's efficacy in the presence of drug degradates.
Main Methods:
- Spectrophotometric determination utilizing 3-Methyl-2-benzothiazolinone hydrazone (MBTH) as a chromogenic reagent.
- Reaction with cerium(IV) ammonium sulphate in an acidic medium to produce a blue-colored product.
- Analysis of absorption maxima at 619 nm and 655 nm.
Main Results:
- The method demonstrated adherence to Beer's law within the concentration range of 24-216 µg/mL.
- High mean percentage recoveries (100.22% ± 0.870% and 100.66% ± 0.642%) were achieved at both absorption maxima.
- The developed method showed comparable results to the British Pharmacopoeia (1993) method.
Conclusions:
- The described spectrophotometric procedure offers a reliable and sensitive method for nortriptyline hydrochloride quantification.
- The method is suitable for analyzing pure drug, dosage forms, and in the presence of its degradate.
- This technique provides a valuable alternative for pharmaceutical quality control analysis.