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ABSTRACT:
A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of Terbinafine HCl and related impurities. The chromatographic separations were achieved on (150x4.6 mm), 5.0 pm make: YMC-Pack ODS-AM, 120A column employing Acetonitrile: methanol and Water pH 7.5, in the ratio of 20:10:10 v/v/v as mobile phase with gradient programmed at flow rate 1.0 mL/min was chosen. Three impurities were eluted within 35 minutes. The detector wavelength of 230 nm was employed.
KEYWORDS: Forced degradation, HPLC, Method validation, Terbinafine.
INTRODUCTION:
Terbinafine hydrochloride (TFH) isanallylamine derivative 1,13 and synthetic antimycotic agent from a new class of compounds, the allylamines 2. Malaria is the world's most important parasitic infection, ranking among the major health and developmental challenges for the poor countries of the world 3. Terbinafine hydrochloride (TBH) is a new antifungal agent widely used for the treatment of many contagious diseases4. Terbinafine Hydrochloride is acts by inhibiting squalene epoxidase, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes 5-7.
1- aphthalenemethanamine, n-(6, 6-dimethyl-2-hepten4-ynyl)-n methyl-, (E)-, hydrochloride, having molecular formula C21H25N.HCl and molecular weight 293. THF is very slightly or slightly soluble in water, freely soluble in anhydrous ethanol, methanol and in methylene chloride, slightly soluble in acetone . Forced degradation studies are used to identify reactions which may occur to degrade a processed product. Usually conducted before final formulation, forced degradation uses external stresses to rapidly screen material stabilities 8.
UV-spectrophotometry is one of the simplest techniques routinely used in pharmaceutical quality control laboratories because of its sensitivity, speed, fair selectivity, low cost and ease of performance. However, the literature on TFH is poor with regard to UVspectrophotometric methods.9. Regulatory agencies recommend the use of stability-indicating methods for the analysis of stability samples. Thus, stress studies are required in order to generate the stressed samples, method development, and its validation 10. It is suggested that stress testing should include the effect of temperature, humidity, light, oxidizing agents as well as susceptibility across a wide range of pH values. It is also recommended that the analyses of stability samples should be carried out by the use of validated stability-indicating testing methods 11, 12.
1. Terbinafine HCl [(E)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride]
2. Impurity-A [(Z)-N-(6,6-dimethyl-2-hepten-4-ynyl)-N-methyl-1-naphthalenemethanamine hydrochloride]
3....