A validated LC method for the quantitative determination of celecoxib in pharmaceutical dosage forms and purity evaluation in bulk drugs

被引：28

作者：

Srinivasu, MK ^{[1
]}

Narayana, CL ^{[1
]}

Rao, DS ^{[1
]}

Reddy, GO ^{[1
]}

机构：

[1] Dr Reddys Res Fdn, Hyderabad 500050, Andhra Pradesh, India

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2000年 / 22卷 / 06期

关键词：

celecoxib; intermediate I; intermediate II; LOD; LOQ;

D O I：

10.1016/S0731-7085(00)00303-4

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

A new reversed-phase, isocratic LC method was developed for the quantitative determination of COX-2 inhibitor celecoxib in bulk drugs and in pharmaceutical dosages. The proposed method is also applicable for the purity evaluation of celecoxib in bulk drugs. 5-Methyl 2-Nitro phenol has been used as internal standard for the quantitative determination of celecoxib. The method has been completely validated and proven to be rugged. The limit of detection (LOD) and limit of quantitation (LOQ) for celecoxib impurities namely, 4-hydrazino benzene sulfonamide (Intermediate I) and 1-(4-methyl phenyl)-4,4,4-trifluro butan-1,3-dione (Intermediate II) were found to be 32.0 and 97 ng, respectively. The active pharmaceutical ingredient was extracted from its finished dosage form (capsule) using methanol. The percentage recoveries ranged from 90.7 to 93.8. The stability studies were performed for celecoxib solution placed on laboratory bench and in refrigerator for hundred days. The samples were found to be stable for the study period. (C) 2000 Elsevier Science B.V. All rights reserved.

引用

页码：949 / 956

页数：8