Validated stability-indicating high performance thin layer chromatographic method for determination of zaltoprofen in pharmaceutical dosage formulation

Der Pharmacia Lettre

Kalpana G. Patel¹ 

关键词: Kalpana G. Patel;    Ruchita G. Gadhavi;    Neha B. Panchal;    Chirag B. Patel;    Mitesh H. Motisariya;    Purvi A. Shah;    Zaltoprofen;    Forced degradation study;    HPTLC;    stability;    validation;   

DOI  :  

学科分类：药理学

来源: Scholars Research Library

【 摘 要 】

A specific stability indicating high-performance thin-layer chromatographic method for analysis of zaltoprofen both as a bulk drug and in formulation was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of Methanol: Ethyl acetate: Toluene (1:1:3, v/v/v). This system was found to give compact spots for Zaltoprofen (Rf value of 0.59). Zaltoprofen was subjected to various accelerated conditions, acid and alkali hydrolysis, oxidation, wet heat treatment and photo degradation. Densitometric analysis of zaltoprofen was carried out in the absorbance reflectance mode at 240 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 1000-2000ng/band with regression coefficient, 0.9924. The overall % recovery was found between 100.33 to 100.68% which reflect that the method is free from interference of the impurities and other additives used in tablet formulation. Relative standard deviations were always less than 2%. The limits of detection and quantitation were 90.982 ng/band and 275.704 ng/band respectively. Moreover, the method could effectively separate the drug from its degradation products; hence it can be employed as a stability indicating one.

【 授权许可】

CC BY