Decomposition of Vitamins in Multivitamin Syrups of Different Brands under Various Storage Conditions

Abstract

Stability of multivitamins containing drug products especially the syrups remains one of the most important factor which restrains from getting the desired therapeutic effects as its ingredients decompose quickly as compared to other Active Pharmaceutical Ingredients (APIs), therefore, stability assessment is necessary to check the effect of climatic conditions on syrups’ decomposition. The study is aimed to assess the level of decomposition of vitamins in different syrups by placing them in stability chambers with different storage conditions and then comparison of assay contents of ingredients in different syrups. Different brands were selected for the estimation of assay values of vitamins/ingredients when stored at Real Time and Accelerated stability conditions as recommended by ICH for the countries categorized in climatic zone IV-A. The samples then analyzed by different analytical techniques such as HPLC, UV- Spectrophotometry and redox titration method at 3rd and 6th month timepoints. The stability study conducted showed that nicotinamide had assay values ranging from 30% to 95%, Pyridoxine 79% to 95%, Thiamine 22 % to 66%, Riboflavin 35% to 58% and Ascorbic acid 21% to 71% at real time (300C) storage condition. The study revealed that nicotinamide had assay values ranging from 26% to 89%, Pyridoxine 71% to 94%, Thiamine 9 to 35%, Riboflavin 24 to 55%, and Ascorbic acid 10 to 55% at accelerated (400C) storage condition. The most stable ingredient was Pyridoxine which showed assay values ranging from 74% to 95% and the most stable sample was Sample no A1. It is evident from the data presented that the degradation is more frequent when the product were stored under accelerated conditions i.e. 400C±2/75%±5RH when compare with the results of stability studies conducted under real time stability studies’ conditions i.e. 300C±2 C/65%±5RH. It is concluded that such products must be stored below 25oC. The manufacturers of such products should mention ‘Store Below 25 C0’ on the label and outer carton of the product.