STABILITY TESTING IN THE FORMULATION OF CEFTRIAXONE TAZOBACTAM INJECTION

Shithin Ann Varghese*, Bunu Khatiwara, Ayesha Syed, Preeti Karwa, Salikh Salim, Beena P.

ABSTRACT

Injections are liquid dosage forms which are designed to be injected, that have quicker action. They do not undergo first-pass metabolism. Stability is a crucial and important facet of pharmaceutical dosage forms. Determination of storage conditions, packaging materials and labelling requirements is desirable through stability studies. At different conditions, the accelerated stability study and reconstituted stability study can be performed in order to determine the stability. In accelerated stability studies, by increasing the Temperature (400C) and relative humidity (75%), we accelerate the degradation of the product. At various time intervals such as initial, 1, 2, 3 and 6 months, the samples were withdrawn from the chamber. The evaluation tests were then executed. From the results of the test, it was concluded that the injection is stable for 6 months under accelerated conditions. In the reconstitution stability study, we reconstituted the drug with different diluents and then it was kept under room temperature (NMT 25°C) and refrigerated conditions (2-8°C). The samples are then withdrawn at various time intervals such as initial, 6 hours, 12 hours, 24 hours, 72 hours, 7th day and 10th day, and evaluation tests are executed. From the result of the tests, it was concluded that the injection is stable for 24 hours at room temperature and stable for 10 days under refrigerated conditions.

Keywords: Stability, Injections, Ceftriaxone, Tazobactam, Membrane Filtration.