Assessment of different commercial brands of Tamoxifen 10 mg tablets marketed in Yemen as anti-breast cancer

ABSTRACT

Breast cancer is one of the most common cancers in women; one, out of nine women will have breast cancer in her life time. Tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is 2-[4-[1,2-diphenyl-1 -buteny l]-phenoxy]-N,N-dimethylethanamine. Tamoxifen is the first anti-estrogen to be used successfully for the treatment of all stages of breast cancer. Several laboratory principles, described 20 years ago, have been tested in clinical trials and became the standard treatment approach for women with breast cancer. The aim of this study is to evaluate the quality and quantity of the commercial brands of tamoxifen 10 mg tablets which are marketed in Yemen. We have selected five items of tamoxifen 10 mg, Tamocit [Ram-Pharma] Novofen, [Remedca], Nolvadex [Astrazenca], Tamoxifen [Amriya] and Zymplox [Gene-Pharma] of five different commercial brands, which are registered in the Supreme Board of Drugs and Medical Appliance of Yemen. We have applied the qualitative and quantitative analysis for evaluating these items and comparing them with Reference Standard of tamoxifen citrate. The limit of content of assay of tamoxifen tablet is [90-110%] [B.P.] and the dissolution content not less than 75% [Q] of the labeled amount of tamoxifen tablets is dissolved in 30 minutes [USP]. The results of analysis of these five items of tamoxifen tablet 10 mg were evaluated. They showed that the qualitative and quantitative analysis were complied with B.P. and USP requirements and there was no significant difference between the results of assays of commercial companies [p < 0.05]