STABILITY-INDICATING HPLC METHOD FOR THE DETERMINATION OF THE STABILITY OF EXTEMPORANEOUSLY PREPARED NOREPINEPHRINE PARENTERAL SOLUTIONS

A stability-indicating HPLC method was developed for analysis of norepinephrine in the presence of the degradation products. The stability of extemporaneously compounded norepinephrine syringes was investigated using this method. The sterile preparations of norepinephrine were compounded to the strength of 8 mu g/mL in accordance with USP (United States Pharmacopeia) < 797 > standards. To carry out the stability testing of these products, these syringes were stored under three different temperature conditions of -20 degrees C, 2-6 degrees C, 22-25 degrees C, and light-protected at 22-25 degrees C. Three injections from each temperature were withdrawn and were assessed for stability on days 0, 7, 15, 21, and 30 as per the USP guidelines. The assay of norepinephrine was examined by this calibrated stability-indicating HPLC method. No precipitation, cloudiness, or color change was observed during this study at all temperatures. The assay content by HPLC revealed that norepinephrine syringes retain greater than at least 90% of the initial concentrations for 30 d. Norepinephrine syringes in the final concentration of 8 mu g/mL and diluted in normal saline are stable for at least 30 d under all the conditions studied. The stability analysis results show that the shelf-life observed was far better than their recommended expiration dates.