VALIDATED STABILITY-INDICATING HPTLC METHOD FOR THE DETERMINATION OF PROPAFENONE HYDROCHLORIDE IN TABLETS AND THE GC-MS IDENTIFICATION OF ITS DEGRADATION PRODUCTS

Abstract

A novel stability-indicating TLC method for determination of propafenone hydrochloride (PRO) in bulk drug and POLFENON tablets. Normal-phase high performance thin layer chromatographic separation was achieved by use of silica gel 60 F₂₅₄ plates and mixture of chloroform–methanol–acetic acid 99.5% (7.9:2:0.1, v/v/v) as the mobile phase. Linear calibration function was obtained (r ² = 0.9987) with respect to peak area in the concentration range of 0.1–3.2 µg/spot. Densitometric analysis of PRO and its forced-degradation products was carried out in the absorbance mode at 316 nm. Limits of detection and quantification were 0.02 and 0.08 µg/spot, respectively. PRO was subjected to stress conditions for obtainment of hydrolytic, oxidative, photolytic, and thermal degradation products. The GC-MS technique was applied to identification of the degradants. The elaborated method was validated using ICH guidelines. The linearity, accuracy (99.24%), precision (intraday RSD 1.61%), and specificity were satisfactory. The validated stability indicating method enables reproducible and selective analysis of propafenone hydrochloride in pharmaceutical dosage form.

Keywords:

• antiarrhythmic drugs
• degradation products
• GC-MS
• HPTLC-densitometry
• orally administrated pharmaceuticals
• propafenone hydrochloride

Notes

PTA, percent of total area of the chromatogram. Ph. Eur. 7.0: present in the European Pharmacopoeia.

*acceptance criteria: correlation ≥ 0.998, mean recovery: 100 ± 3%, precision: RSD ≤ 3%.