Stability-indicating HPLC method for the determination of the stability of oxytocin parenteral solutions prepared in polyolefin bags

Abstract

Oxytocin is very commonly used in clinical settings and is a nonapeptide hormone that stimulates the contraction of uterine smooth muscles. In this study the stability of extemporaneously compounded oxytocin solutions was investigated in polyolefin bags. The sterile preparations of oxytocin were compounded to the strength of 0.02 U/mL in accordance with United States Pharmacopeia (USP) <797> standards. In order to carry out the stability testing of these parenteral products, the solutions were stored under three different temperature conditions of −20°C (frozen), 2-6°C (refrigerated), and 22-25°C (room temperature). Three solutions from each temperature were withdrawn and were assessed for stability on days 0, 7, 15, 21, and 30 as per the USP guidelines.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 oxytocin was examined by an HPLC method at each time point. No precipitation, cloudiness or color change was observed during this study at all temperatures. The assay content by HPLC revealed that oxytocin retains greater than at least 90% of the initial concentrations for 21 days. There was no significant change in pH and absorbance values for 21 days under all the conditions of storage. Oxytocin parenteral solutions in the final concentration of 0.02 U/mL and diluted in normal saline are stable for at least 30 days under frozen and refrigerated conditions for 30 days. At the room temperature, the oxytocin solutions were stable for at least 21 days. The stability analysis results show that the shelf-life of 21 days observed in this study was far better than their recommended expiration dates.

Isomerism of Cycloserine and Its Protonated Form

“…In vitro studies demonstrated that d-cycloserine is also an effective, moderately specific partial agonist at the glycine site coupled to Nmethyl-d-aspartate (NMDA) receptors. [2] Because of its action on NMDA receptors, d-cycloserine is commonly used in a number of clinical treatments of anxiety [3][4][5] and obsessivecompulsive disorders. [6,7] The S enantiomer (l-cycloserine) exhibits the ability to increase the levels of the inhibitory neurotransmitter g-aminobutyric acid (GABA) as well as to inhibit the pyridoxal-5'-phosphate (PLP) enzyme GABA-transferase.…”

D-cycloserine nasal formulation development for anxiety disorders by using polymeric gels

“…pH is a physical parameter that indicates the stability of the products as the change in pH can alter the property of solutions (42). "Average baseline human nasal pH is approximately 6.3".…”

Medication Safety in Intravenous Therapy: A Compatibility Study of Clonidine with Drugs Frequently Used in Intensive Care

“…A calibration curve was measured in every run. Drug admixtures were considered chemically compatible if the concentrations of each drug remained between 90 and 110% of the original concentration [ 29 , 33 , 34 , 35 , 36 , 37 , 38 ]. As the samples were stored at −80 °C to prevent any drug reaction or degradation, prior to drug quantification via HPLC they were thawed under light protection at room temperature (22–24 °C).…”