TLC DETERMINATION OF TIAPRIDE HYDROCHLORIDE AND ITS IMPURITIES IN PHARMACEUTICALS

Abstract

A simple and sensitive HPTLC method for separation and determination of tiapride hydrochloride and its degradation products has been developed and evaluated. Analysis of tiapride hydrochloride and impurities III, VII, and VIII, was performed on silica gel 60 F₂₅₄ HPTLC plates using methylene chloride-methanol-concentrated ammonia, 9:1.6:0.1 (v/v) as mobile phase. Detection was performed at 240 nm. All validation requirements, specificity, linearity (r ≥ 0.997), recovery (95.08–100.39%), limit of quantification (0.1–0.2%), and robustness were examined and fulfilled, and the proposed method can be successfully applied for the quality control analysis of commercially available tablets and injections.

Keywords:

• dosage forms
• HPTLC
• impurities
• pharmaceutical preparations
• quantification
• tiapride hydrochloride

ACKNOWLEDGMENT

This work was supported by the Ministry of Science and Technological Development of the Republic of Serbia, Contract No. 172033.

Notes

^a SD, Standard deviation. n = 6.

n.d., not detected - concentration below the limit of detection of the method.