Lorazepam Stability in Parenteral Solutions for Continuous Intravenous Administration

1996 ◽  
Vol 30 (4) ◽  
pp. 343-346 ◽  
Author(s):  
Lori L Hoey ◽  
Kyle Vance-Bryan ◽  
Diann M Clarens ◽  
David H Wright ◽  
Frank N Konstantinides ◽  
...  
Keyword(s):  
Polyvinyl Chloride ◽  
Hplc Analysis ◽  
Visual Inspection ◽  
Degradation Products ◽  
Significant Loss ◽  
Test Solution ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Concentration Determination ◽  
The Stability

OBJECTIVE: To determine the stability of lorazepam over a 24-hour period when prepared in polyvinyl chloride (PVC) bags at initial concentrations of 0.08 and 0.5 mg/mL. DESIGN: Each concentration was studied at room (21°C) and refrigerator (4°C) temperatures in dextrose 5% (D5W) and NaCl 0.9% solutions. Duplicate test solution admixtures were prepared for each lorazepam concentration, diluent, and temperature. At 0, 1, 4, 8, and 24 hours, duplicate samples were obtained for visual inspection, pH determination, and concentration determination by stability-indicating, reverse-phase HPLC analysis. Compared with baseline, peaks for lorazepam degradation products were not found on any of the study chromatograms. RESULTS: In D5W and NaCl 0.9% solutions, lorazepam loss in excess of 10% by HPLC analysis occurred for concentrations of 0.08 and 0.5 mg/mL at 1 and 4 hours, respectively. CONCLUSIONS: These data suggest that significant loss of lorazepam occurs as the probable result of sorption to PVC bags when admixed in both D5W and NaCl 0.9% solutions at 21 and 4°C.

Stability of Intravenous Famotidine Stored in Polyvinyl Chloride Syringes

DICP ◽  
1989 ◽  
Vol 23 (7-8) ◽  
pp. 588-590 ◽  
Author(s):  
Linda S. Bullock ◽  
Joseph F. Fitzgerald ◽  
Helen I. Mazur
Keyword(s):  
Polyvinyl Chloride ◽  
Repeated Measures ◽  
High Performance ◽  
Hplc Analysis ◽  
Time Effect ◽  
Sterile Water ◽  
Reverse Phase ◽  
Repeated Measures Analysis ◽  
The Stability ◽  
Over Time

The stability of intravenous famotidine in dextrose 5% injection (D5W), NaCl 0.9% injection (NS), and sterile water for injection stored in polyvinyl chloride (PVC) syringes at 4°C for 14 days was studied. The concentration of famotidine samples was determined at time 0, 7 days, and 14 days by reverse-phase high-performance liquid chromatography. Samples were inspected for visual changes and tested for changes in pH. Results of the HPLC analysis indicated that the famotidine samples remained within 94-100 percent and 99-103 percent of the time 0 concentrations at 7 and 14 days, respectively. Repeated measures analysis of variance demonstrated a significant time effect on famotidine concentration as concentrations changed over time (p<0.01). This change was small in magnitude, however, and concentrations decreased at 7 days and increased at 14 days. Famotidine is stable at a concentration of 2 mg/mL in D5W, NS, and sterile water for injection stored in PVC syringes at 4°C for 14 days.

scholarly journals Choline Salicylate Analysis: Chemical Stability and Degradation Product Identification

Molecules ◽  
2019 ◽  
Vol 25 (1) ◽  
pp. 51
Author(s):  
Katarzyna B. Wróblewska ◽  
Szymon Plewa ◽  
Paweł Dereziński ◽  
Izabela Muszalska-Kolos
Keyword(s):  
Hydrogen Peroxide ◽  
Hplc Analysis ◽  
Degradation Products ◽  
Hydrolytic Degradation ◽  
Acid Media ◽  
Product Identification ◽  
The Stability ◽  
Degradation Degree ◽  
Effect Of Light

Choline salicylate (CS) as a derivative of acetylsalicylic acid is commonly used in different drug forms. In medicine, it is applied topically to inflammation of the oral cavity mucosa and in laryngology. However, this substance in the form of an ionic liquid has not been investigated enough. There are no literature studies on stability tests constituting a stage of pre-formulation research. HPLC (Nucleosil C18, 4.6 × 150 mm, 5 μm; methanol-water-acetic acid 60:40:1, 230 nm or 270 nm) and UV (276 nm) methods for the determination of CS in 2% (g/mL) aqueous solutions were developed. Under stress conditions, CS susceptibility to hydrolytic degradation in aqueous medium, hydrochloric acid, sodium hydroxide, and hydrogen peroxide, and the effect of light on the stability of CS solutions were studied with HPLC analysis. The degradation degree of CS and the purity of the solutions were also tested. Choline salicylate has been qualified as practically stable in neutral and acid media, stable in an alkaline medium, very stable in an oxidizing environment, and photolabile in solution. The HPLC-MS/MS method was used to identify 2,3- and 2,5-dihydroxybenzoic acids as degradation products of CS under the tested conditions.

Non-aqueous reverse-phase HPLC analysis of triglycerides

1987 ◽  
Vol 23 (3) ◽  
pp. 209-214 ◽  
Author(s):  
L. J. R. Barrón ◽  
G. Santa-María
Keyword(s):  
Hplc Analysis ◽  
Reverse Phase Hplc ◽  
Reverse Phase

scholarly journals Validated Reverse Phase HPLC Method for the Determination of Impurities in Etoricoxib

2011 ◽  
Vol 8 (s1) ◽  
pp. S119-S126
Author(s):  
S. Venugopal ◽  
U. M. Tripathi ◽  
N. Devanna
Keyword(s):  
Degradation Products ◽  
Sodium Hydroxide Solution ◽  
Hplc Method ◽  
Stress Conditions ◽  
Forced Degradation ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Successful Separation ◽  
Forced Degradation Studies

This paper describes the development of reverse phase HPLC method for etoricoxib in the presence of impurities and degradation products generated from the forced degradation studies. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The degradation of etoricoxib was observed under base and oxidation environment. The drug was found stable in other stress conditions studied. Successful separation of the drug from the process related impurities and degradation products were achieved on zorbax SB CN (250 x 4.6 mm) 5 μm particle size column using reverse phase HPLC method. The isocratic method employed with a mixture of buffer and acetonitrile in a ratio of 60:40 respectively. Disodium hydrogen orthophosphate (0.02 M) is used as buffer and pH adjusted to 7.20 with 1 N sodium hydroxide solution. The HPLC method was developed and validated with respect to linearity, accuracy, precision, specificity and ruggedness.

scholarly journals Quantification of Pimavanserin in Bulk and Tablet Dosage Form Using A Stability Indicating High Performance Liquid Chromatographic Method

2018 ◽  
Vol 24 (4) ◽  
pp. 291-297 ◽  
Author(s):  
Geetha Bhavani Koduri ◽  
Hari Babu Bollikolla ◽  
Ramachandran Dittakavi ◽  
Srinivasu Navuluri
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Degradation Products ◽  
Antipsychotic Agent ◽  
Hplc Method ◽  
Array Detector ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Tablet Dosage

Background: Pimavanserin, an antipsychotic agent, is used to treat patients suffering with Parkinson's disease. Till now no stability indicating reverse phase HPLC method was reported for the quantification of pimavanserin in bulk and tablet dosage form. Hence in the present study, a new sensitive, precise and accurate stability indicating reverse phase HPLC method with photodiode array detector has been developed for the quantification of pimavanserin in bulk and tablet dosage form. Methods: Separation and analysis of pimavanserin was achieved on Kromasil C18 (5 µm, 250 mm × 4.6 mm) column using 0.1M NaH2PO4, methanol and acetonitrile in ratio of 55:30:15 (v/v/v) as mobile phase at 25°C. The flow rate was 1.0 ml/min. The effluents were monitored with detector set at 239 nm. The method validation was done with regard to the guidelines by the International Conference on Harmonization. Pimavanserin was subjected to acid, alkali and neutral hydrolysis, hydrogen peroxide oxidation, thermal degradation, and photo (sunlight) degradation. Results: Linear relationship was obtained between the concentration of drug and peak area response in the range of 4.25-34.0 µg/ml. The limits of detection and quantitation were found to be 0.027 µg/ml and 0.089 µg/ml, respectively. All the validation characteristics were within the acceptance criteria. The peaks of degradation products were well resolved from the pimavanserin peak. Conclusion: The developed and validated method is able to quantify the pimavanserin in the presence of degradation products.

Sign in / Sign up

Export Citation Format

Share Document