2nd International Conference on Fostering Interdisciplinary Research In Health Sciences (ICFIRHS) 2019 (01-May-2019)        |

Journal :   Research Journal of Pharmacy and Technology

Volume No. :   7

Issue No. :  1

Year :  2014

Pages :   23-28

ISSN Print :  0974-3618

ISSN Online :  0974-360X


Registration

Allready Registrered
Click to Login

A Stability Indicating High Performance Liquid Chromatographic Assay (HPLC) for the Determination of Terbinafine Hydrochloride in Bulk Drug Substance



Address:   Hamsa Kassem , Mohamed Amer Almardini, Heba Ghazal
Faculty of Pharmacy, Damascus University, Damascus, Syria.
*Corresponding Author
DOI No: Not Available

ABSTRACT:
A simple, accurate, and stability- indicating reversed phase high-performance liquid chromatography (HPLC) method was developed and validated for the quantitative determination of terbinafine hydrochloride in bulk drug substance. Chromatographic separation was performed using C18 column and an isocratic mobile phase consisting of methanol and acetonitrile (60:40, v/v) with (0.15% triethylamine and 0.15% phosphoric acid) at a flow rate of 0.4 ml/ min. The eluents were monitored by UV photodioide array detector at wavelength of 224nm. The method was statistically validated for linearity, specificity, accuracy, precision, limit of detection, limit of quantification and robustness. The stability – indicating nature of the method had been proved by subjecting terbinafine hydrochloride to acidic hydrolysis, basic hydrolysis, oxidation, thermal and photo degradation. Degradation products resulted from the stress studies did not interfere with the detection of the drug and thus the assay is stability- indicating.
KEYWORDS:
HPLC, stability-indicating, Terbinafine Hydrochloride.
Cite:
Hamsa Kassem , Mohamed Amer Almardini, Heba Ghazal. A Stability Indicating High Performance Liquid Chromatographic Assay (HPLC) for the Determination of Terbinafine Hydrochloride in Bulk Drug SubstanceResearch J. Pharm. and Tech. 7(1): Jan. 2014; Page 23-28.
[View HTML]      [View PDF]



Visitor's No. :   660364