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Spectrophotometric and HPLC method validation for the determination of terbinafine hydrochloride in transungual dosage forms


* Corresponding author
Pharmaceutics Division, Department of Pharmaceutical Sciences, Punjabi University, Patiala (India)


The objective was to develop a simple, specific, economic, precise and accurate HPLC and UV spectrophotometric methods for the quantitative analysis of terbinafine hydrochloride in transungual dosage forms. The HPLC analysis was done using a mobile phase composed of methanol-water (95:5 % v/v) at a flow rate of 1ml/min using UV detector at wave length of 283 nm. The proposed methods were validated for specificity, linearity, accuracy, limit of detection and limit of quantification as per ICH guidelines. The retention time was found to be 8.1 min. Linearity in HPLC and UV spectrophometric method was found to be in the range of 2-50 µg/ml and 5-45 µg/ml, respectively. Both the proposed methods were found to be accurate and precise with recoveries in the range of 98.25 %-102.00 %. The relative standard deviation was found to be within the specified pharmacopeial limits. Further the developed methods were validated and used for estimation of terbinafine hydrochloride in different formulations like creams and dusting powders.


Terbinafine hydrochloride [(2E)-N, 6, 6-Trimethyl-N-(naphthalen-1-ylmethyl) hept-2-en-4-yn-1-amine hydrochloride] is an allylamine derivative reported to have a broad spectrum activity against dermatophytes, certain dimorphic fungi, yeasts and moulds. The drug and its analogues are potent inhibitors of squalene epoxidase, an enzyme present in fungal cells which is important in ergosterol biosynthesis. The irreversible inhibition of this enzyme promotes intracellular squalene accumulation, resulting in disruption of cell wall integrity (1). Oral terbinafine hydrochloride (TH) is used for the treatment of dermatophyte infections of the skin and nails. It is applied topically to the affected areas (2).
Simple HPLC method with UV detection was used for the determination of TH in plasma together with its desmethyl metabolite after liquid–liquid extraction and aqueous back-extraction using acetonitrile and 0.012 M triethylamine: 0.020 M orthophosphoric acid (50: 50, v/v) as mobile phase (3). The same metabolite together with TH and another three metabolites were determined in human plasma, milk and urine (4) by RP-HPLC, likewise as TH ...

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