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ABSTRACT:
Preservatives are those substances that are added into pharmaceutical formulations to increase its shelf life. Prolonged use of formaldehyde in the formulations may lead to cancer and other health related issues. Besides formaldehyde has a bad odor which results in poor patient compliance. In such cases the use of bronopol can prove to be a useful option for industries. It degrades to formaldehyde but slowly and in very low amount that gives preservative action. A simple, precise and sensitive method for bronopol estimation in UV spectrophotometer was developed and validated. The method showed linearity in range of 20-100 pg/ml. LOD and LOQ values were found to be 1.22 and 3.77 pg/ml. Correlation coefficient was found to be 0.994. The developed method was also successfully applied to the pharmaceutical formulation. Stability indicating study of bronopol was also done in various conditions.
KEYWORDS: Bronopol . Preservative, UV Spectrophotometry, Stability indicating study.
INTRODUCTION:
"Preservatives are substances that commonly added to various foods and pharmaceutical products in order to prolong their shelf life." They are added in formulations containing higher water content. This is done in order to avoid any alteration of composition of formulation and to avoid microbial attack that can be faced during the storage [1-2]. Formaldehyde is a preservative which is used but it is carcinogenic in nature. Formaldehyde has a bad odour which results in poor patient compliance [3]. Bronopol is an anti microbial preservative and is added to various pharmaceutical formulations to avoid their degradation. In such cases the use of bronopol can prove to be a useful option for industries. The effective concentration of bronopol in pharmaceutical preparations ranges from 0.01 to 0.1%, with the common concentration being 0.02% [4]. It degrades to formaldehyde but slowly and in very low amount that gives preservative action.
MATERIALS AND METHODS:
A double beam UV/Visible spectrophotometer (Labtronic-LT2900) was employed with spectral bandwidth of 1...