Dissolution Testing and Potentiometric Assay of Sertraline Hydrochloride in Batch and FIA Conditions

Abstract

An electrochemical polyvinyl chloride membrane sensor for sertraline (Ser) was prepared based on the ion associate of sertraline with phosphotungstic acid. The sensor was fully characterized in terms of its membrane composition, life span, effect of soaking, pH, interferences, and temperature and exhibited an average Nernestian response (61.6 ± 0.9 mV/decade) in the concentration range of 1.0 × 10⁻² –5.0 × 10⁻⁵ M. Sertraline was assayed potentiometrically in its pure solutions and pharmaceutical preparations using the developed electrode under batch and flow injection conditions and the recovery values ranged from 93.44–101.12%, with a relative standard deviation of 0.53–1.27%.

The sensor was successfully applied to the determination of the dissolution profile study of (Ser) tablets and the results were validated by comparison with spectrophotometric assays according to the quality control unit of the tablets pharmaceutical company producers. The results obtained from the proposed electrode were statistically analyzed and compared to a reported method. No significant difference was observed regarding both accuracy and precision.

Keywords:

• Dissolution profile
• Flow injection analysis
• Phosphotungstic acid
• Polyvinyl chloride
• Potentiometry
• Sertraline hydrochloride

Acknowledgments

The authors would like to express their thanks to Mr. Mohamed Bahgat, Head of the Logistics Department in The Egyptian Company for Chemicals and Pharmaceuticals (ADWIA) for providing us with the pure material of the drug and the dissolution method for the drug.

Notes

*SSM: Separate solution method.

**MSM: Matched solution method.

1. Taken mg per 50 mL. 2. Relative standard deviation (five determinations).

*Figures between parentheses are the corresponding tabulated values.