Stability-indicating High Performance Thin Layer Chromatographic Determination of Clozapine in Tablet Dosage Form
Journal Title: Journal of Pharmaceutical Sciences and Research - Year 2009, Vol 1, Issue 4
Abstract
A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of Clozapine in pharmaceutical dosage form was developed and validated. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system comprised of toluene - methanol - ethyl acetate - ammonia (8:2:1:0.1, v/v/v/v). This system was found to give compact spots for Clozapine (Rf value of 0.25). Clozapine was subjected to acid and alkali hydrolysis, oxidation, photochemical degradation and thermal degradation. Also, the degraded product was well separated from the pure drug. Densitometric analysis of Clozapine was carried out in the absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed good linear relationship with coefficient of regression value, r2 = 0.9991 in the concentration range 10.8-108.0 ng spot-1. The value of correlation coefficient, slope and intercept were 0.9995, 22.49 and 18.06, respectively. The method was validated for precision, recovery, ruggedness and robustness. The limits of detection and quantitation were 5.4 and 10.8 ng spot-1, respectively. The drug undergoes degradation under acidic, basic, photochemical degradation and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different Rf values. The samples degraded with hydrogen peroxide showed no additional peak. This indicates that the drug is susceptible to acid-base hydrolysis degradation, photochemical degradation and thermal degradation. Statistical analysis proves that the method is reproducible and selective for the estimation of said drug. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.
Authors and Affiliations
Zahid Zaheer , Mazhar Farooqui , S. R. Dhaneshwar
Keywords
Related Articles
- EP ID EP149908
- DOI -
- Views 123
- Downloads 0
Expression of Cholera toxin B subunit in Banana callus culture
Plants present a low cost agriculturally based effective production system for high value therapeutic system. The process of developing an edible vaccine begins by selecting a suitable vaccine gene of a pathogen and sele...
Fifth Disease: A review
The fifth disease, which is known by many other names, is characterized by fever, rash and redness of the skin. It is caused by a small DNA virus named Parvovirus B19.The disease occurs more frequently in chil...
Antidiabetic, Antioxidant and Antibacterial Activities of Leaf extracts of Adhatoda zeylanica. Medic (Acanthaceae)
The present work is aimed at exploring the antidiabetic, antioxidant and antimicrobial activities of leaf extracts of Adhatoda zeylanica, Medic (Acanthaceae). The hexane (HE), chloroform (CE) and methanolic (ME) extracts...
Stability-indicating High Performance Thin Layer Chromatographic Determination of Clozapine in Tablet Dosage Form
A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of Clozapine in pharmaceutical dosage form was developed and validated. The method employed TLC alumini...
Thin Layer Chromatodraphy Method for the Determination of Ternary Mixture Containing Salbutamol Sulphate, Bromhexine Hydrochloride and Etofylline
Simple, rapid, accurate, precise, reliable and economical thin layer chromatographic and spectrophotometric methods have been proposed for the resolution and determination of Salbutamol sulphate (SS), Brombexine hydrochl...