Abstract

STABILITY STUDIES OF NITROGLYCERINE IN DIFFERENT DOSAGE FORMS (AS PER ICH GUIDELINES)

Dr. M. Nappinnai* and K.Sonia

ABSTRACT

The objective of stability study is to determine the shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Stability study is of three types that is physical, chemical and microbial stability. Nitroglycerin different dosage form like sublingual tablets,Injection and ointment were studied over a 135 days period to determine stability in terms of loss of strength, uniformity of tablets, and degradation of the drug itself. The sample include tablet, injection and ointmentwere analysed by semiauomated procedure. There is not much difference when the tablets are stored in a refrigerator or kept at ordinary conditions, as the degradation is 15-16% in both the cases. The drug in ointment is unstable at ambient conditions showing 50% degradation. Humidity conditions accelerate the drug degradation in injectable form. It is quite stable when stored in water though there is loss of 33%w/w from initial content. It is observed that the refrigerating condition also degrades the drug to 50%.

Keywords: Stability study, Stability study, Nitroglycerin, Potency, ICH guidelines.