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ABSTRACT:
Nicotine hydrogen tartrate was subjected to different stress test conditions and solutions so obtained were further subjected to develop a stability-indicating high performance liquid chromatographic (HPLC) method. The drug was well separated from degradation products using a reversed-phase (Intersil C-18) column and a mobile phase comprising of methanol: buffer in ratio 25:75 v/v with a positive peak purity index. The detection limit and quantification limit were found to be 0.118 mg/ml and 0.354 mg/ml, respectively. The method was validated for precision, robustness, linearity and range. Results obtained after validation study, indicate that the proposed single method allowed analysis of nicotine hydrogen tartrate, in the presence of their degradation products formed under a different stress conditions.
KEYWORDS: Nicotine hydrogen tartrate, HPLC, Validation, Stability, Degradation.
INTRODUCTION:
Nicotine hydrogen tartrate (NHT) (Fig 1) is a pure crystalline salt of nicotine. Chemically it is (-)-1-Methyl-2- (3-pyridyl) pyrrolidine (+)-bitartrate salt. Nicotine is a potent parasympathomimetic alkaloid, it acts as a nicotinic acetylcholine receptor agonist. In smaller doses, its acts as a stimulant in mammals, while high amounts (30-60 mg) can be fatal. 1-2
To date, all analytical methods described in literature for the determination of NHT involve potentiometric and spectrophotometric methods3-4. The aim of the present study was to develop an accurate, precise, specific, reproducible and stability indicating HPLC method for the estimation NHT. The NHT was intentionally degraded by acid, base, oxide, dry heat, wet heat and UV light treatment to check the stability and to develop stability indicating assay method 5-13. The developed analytical method was validated by means of precision, robustness, linearity and range. 14
MATERIALS AND METHODS:
Chemicals and reagents:
NHT was supplied by J.L. Chaturvedi College of Pharmacy, Nagpur.
All the chemicals used for the study were of AR and HPLC grade. Millipore membrane filters (0.45µ) were used for filtration of mobile phase and working solutions. Double distilled and membrane filtered water was used throughout the experimental work.
HPLC instrumentation and conditions:
HPLC model Shimadzu SPD20-A equipped with ALC pump having variable wavelength UV- Visible detector with manual injector (20 µL). Each chromatogram was analyzed with LC Solutions software. Separations were achieved by using an Intersil C18 column (150 mm × 4.6 mm, 5 µm). The mobile phase consisted of a methanol:...