Pralidoxime Chloride Stability-Indicating Assay and Analysis of Solution Samples Stored at Room Temperature for Ten Years

1989 ◽  
Vol 78 (2) ◽  
pp. 132-136 ◽  
Author(s):  
Alan C. Schroeder ◽  
Joseph H. Digiovanni ◽  
Jurgen Von Bredow ◽  
Melvin H. Heiffer
Keyword(s):  
Room Temperature ◽  
Stability Indicating ◽  
Pralidoxime Chloride

Stability of Ceftazidime and Vancomycin Alone and in Combination in Heparinized and Nonheparinized Peritoneal Dialysis Solution

1994 ◽  
Vol 28 (5) ◽  
pp. 572-576 ◽  
Author(s):  
Leigh M. Vaughan ◽  
Cathy Y. Poon
Keyword(s):  
Peritoneal Dialysis ◽  
Room Temperature ◽  
Color Change ◽  
Hplc Assay ◽  
Time Points ◽  
Stability Indicating ◽  
Dialysis Solution ◽  
Peritoneal Dialysis Solution ◽  
The Stability

OBJECTIVE: To examine the stability of ceftazidime, vancomycin, and heparin, alone and in combination, in dialysis solution over six days at three temperatures. DESIGN: Nine 250-mL Dianeal PD-2 dextrose 1.5% bags were prepared with ceftazidime, vancomycin, and heparin alone and in combination at set concentrations of 100 μg/mL, 50 μg/mL, and 1 unit/mL, respectively. Three bags of each mixture were stored at 4, 25, and 37°C. Duplicate samples for analysis were removed from each bag at the following time points: premix, 0, 12, 24, 48, 72, 96, 120, and 144 hours. MAIN OURCOME MEASURES: Each sample was examined visually for signs of cloudiness and precipitation. Each sample was analyzed by stability-indicating HPLC assay for ceftazidime and vancomycin, with stability defined as less than 10 percent degradation of drug overtime. RESULTS: No color change or precipitation was observed in any bag. Vancomycin with or without heparin was stable for 5–6 days at 4, 25, and 37°C. Ceftazidime with and without heparin was stable for 6 days at 4°C, 4 days at 25°C, and less than 12 hours at 37 °C. Vancomycin plus ceftazidime with and without heparin was stable for 6 days at 4 °C and 25°C, and 4–5 days at 37 °C, Ceftazidime plus vancomycin with or without heparin was stable for 6 days at 4°C, 2–3 days at 25°C, and 12 hours at 37 °C. CONCLUSIONS: Bulk preparations of ceftazidime and vancomycin, alone and in combination and with or without heparin in Dianeal PD dextrose 1.5% solution, are sufficiently stable for use up to 6 days under refrigeration or 48 hours at room temperature.

scholarly journals Development and Validation of Stability-Indicating HPLC Methods for the Estimation of Lomefloxacin and Balofloxacin Oxidation Process under ACVA, H2O2, or KMnO4 Treatment. Kinetic Evaluation and Identification of Degradation Products by Mass Spectrometry

Molecules ◽  
2020 ◽  
Vol 25 (22) ◽  
pp. 5251
Author(s):  
Barbara Żuromska-Witek ◽  
Paweł Żmudzki ◽  
Marek Szlósarczyk ◽  
Anna Maślanka ◽  
Urszula Hubicka
Keyword(s):  
Room Temperature ◽  
Oxidation Process ◽  
Degradation Products ◽  
Isocratic Elution ◽  
Kinetic Evaluation ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Azo Initiator ◽  
Development And Validation ◽  
Kinetics Of

The oxidation of lomefloxacin (LOM) and balofloxacin (BAL) under the influence of azo initiator of radical reactions of 4,4′-azobis(4-cyanopentanoic acid) (ACVA) and H2O2 was examined. Oxidation using H2O2 was performed at room temperature while using ACVA at temperatures: 40, 50, 60 °C. Additionally, the oxidation process of BAL under the influence of KMnO4 in an acidic medium was investigated. New stability-indicating HPLC methods were developed in order to evaluate the oxidation process. Chromatographic analysis was carried out using the Kinetex 5u XB—C18 100A column, Phenomenex (Torrance, CA, USA) (250 × 4.6 mm, 5 μm particle size, core shell type). The chromatographic separation was achieved while using isocratic elution and a mobile phase with the composition of 0.05 M phosphate buffer (pH = 3.20 adjusted with o-phosphoric acid) and acetonitrile (87:13 v/v for LOM; 80:20 v/v for BAL). The column was maintained at 30 °C. The methods were validated according to the ICH guidelines, and it was found that they met the acceptance criteria. An oxidation process followed kinetics of the second order reaction. The most probable structures of LOM and BAL degradation products formed were assigned by the UHPLC/MS/MS method.

scholarly journals Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome

2021 ◽  
Vol 26 (4) ◽  
pp. 395-404
Author(s):  
Ankit Rochani ◽  
Vinh Nguyen ◽  
Robin Becker ◽  
Walter Kraft ◽  
Gagan Kaushal
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Color Change ◽  
Storage Condition ◽  
Stability Study ◽  
Neonatal Abstinence Syndrome ◽  
Limited Information ◽  
Abstinence Syndrome ◽  
Stability Indicating ◽  
The Stability

OBJECTIVE In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography–mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time. METHODS A stability-indicating LC-MS method was developed to map the potential degradation peaks of buprenorphine when exposed to acidic, basic, and oxidative conditions. This method was used to study the stability of compounded buprenorphine oral syringes stored under refrigeration (2°C–8°C) and room temperature (25°C ± 2°C with 60% relative humidity). Syringes from each storage condition were assessed for stability using pH meter and stability-indicating LC-MS assay for 30 days. RESULTS Buprenorphine gets completely degraded in the presence of acid at the end of 1 hour of exposure. Various degradation peaks were identified using LC-MS assay for buprenorphine under acidic, basic, and peroxide conditions. Stability study of oral buprenorphine syringes showed no precipitation, cloudiness, or color change during this study at all storage conditions. The LC-MS assay revealed that buprenorphine oral syringes retained greater than 90% of the initial concentrations for 30 days. CONCLUSIONS Highly sensitive stability-indicating LC-MS method was developed for studying the stability of extemporaneously compounded buprenorphine oral syringes. This study demonstrates that buprenorphine extemporaneous formulation prepared according to the manufacturers' recommendations is stable under refrigerated or room temperature conditions for 30 days in oral plastic syringes.

Stability of 4 Intravenous Drug Formulations in Prefilled Syringes Stored Frozen for Up to 60 Days

2020 ◽  
pp. 001857872097388
Author(s):  
Michael C. Storm ◽  
Joyce E. Broyles ◽  
Oscar R. Herrera ◽  
Richard A. Helms
Keyword(s):  
Drug Delivery ◽  
Room Temperature ◽  
Intravenous Drug ◽  
Drug Formulations ◽  
Stability Indicating ◽  
Antibiotic Drug ◽  
Stability Data ◽  
Prefilled Syringes ◽  
The Cost ◽  
Zero Time

Purpose: Prefilled drug syringe use may reduce the cost of routine antibiotic drug delivery. Storage of prefilled syringes frozen (−20°C) or refrigerated (4°C-5°C), can optimize the use of robotic syringe filling systems if acceptable stability data is gathered per USP 797 standards. Methods: Four intravenous (IV) drug formulations were prepared from bulk standard solutions and filled into 10 mL syringes using an Intellifill© IV Robot. Formulations were Piperacillin (2.0 g) and Tazobactam (0.25 g) as 2.25 g in 10 mL; Piperacillin (3.0 g) and Tazobactam (0.375 g) as 3.375 g in 10 mL; Cefuroxime as 1.5 g in 11 mL; and Vancomycin as 1.0 g in 10 mL. Concentrations were assayed at “zero time,” and after 21, 45, and 60 days frozen. Syringes were warmed to room temperature (RT) by gently rolling in hands. Three syringes of each formulation were assayed by stability-indicating HPLC per USP procedures. Assay results are the average of 5 injections of samples from each syringe upon return to RT and repeated for 3 separate syringes maintained at RT for 24 hours. Results: All formulations were stable out to 60 days frozen. Both of the piperacillin/tazobactam formulations were also stable when kept at refrigerated temperature for 9 days. Conclusion: Piperacillin/Tazobactam formulations can be stored frozen (−20°C) for up to 60 days with no appreciable loss. Cefuroxime and Vancomycin formulations can be stored frozen for up to 60 days. Both Piperacillin/Tazobactam formulations can be refrigerated for up to 9 days. Implementation of larger batch compounding coupled with frozen syringe storage and delivery could result in enhanced uniformity of composition and significant manpower savings.

scholarly journals Stability Indicating and Evaluation of Preservers in Cocos Nucifera Water by means of HPTLC Techniques

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 388-392
Author(s):  
Aditya Raghava Golakoti ◽  
Raju PSN ◽  
Jaiganesh S ◽  
Amrin S A
Keyword(s):  
Water Samples ◽  
Room Temperature ◽  
Cocos Nucifera ◽  
Diagnostic Techniques ◽  
Coconut Water ◽  
Flame Photometry ◽  
Sodium Potassium ◽  
Stability Indicating ◽  
Microbial Development ◽  
The Impact

This examination manages the steadiness and successful utilization of additives in the coconut water. The new coconut water was separated in Aseptic zone through whatman channel paper and equivalent amounts of new coconut water are pressed in self sealable spreads. Propylparaben and Benzoic corrosive are utilized as additives of various qualities. These examples are put away for around 1 to 12 weeks at room temperature and refrigerated condition at 25°C. Tests are tried by various diagnostic techniques like pH, Turbidimetry, Titrimetry, Flame photometry, and HPTLC the shading change of tests are likewise watched. The adjustment in the new coconut water and tests with the additives are estimated for pH at customary time stretches to such an extent that the pH is kept up in the middle of 5.5-6 and to decide the microbial development by utilizing Turbidimetry, % of magnesium and % of ascorbic corrosive by Titrimetry. Sodium Potassium particles are controlled by utilizing fire photometry and to decide the sugars by utilizing HPTLC. The expansion of the additives improved the straightforwardness of the examples and the impact of additives on the Magnesium, Sodium, Potassium, Ascorbic corrosive, sugars are less with the end goal that the put-away coconut water samples can be stuffed in a self-sealable spread.

Stability of a pyrimethamine suspension compounded from bulk powder

2017 ◽  
Vol 74 (24) ◽  
pp. 2060-2064 ◽  
Author(s):  
Paul O. Lewis ◽  
David B. Cluck ◽  
Jessica D. Huffman ◽  
Amanda P. Ogle ◽  
Stacy D. Brown
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Stability Indicating ◽  
Color Changes ◽  
Stability Indicating Method ◽  
Bulk Powder ◽  
Subsequent Application ◽  
Temperature Ranges ◽  
The Stability

Abstract Purpose Development of a stability-indicating high-performance liquid chromatography (HPLC) method for pyrimethamine analysis, with subsequent application of that method to assess the 90-day stability of a pyrimethamine suspension compounded from bulk USP-grade pyrimethamine powder, is described. Methods A stability-indicating method of HPLC with ultraviolet detection specific to pyrimethamine was developed according to pharmacopeial recommendations and validated. The method was applied to investigate the stability of a 2-mg/mL pyrimethamine suspension in a vehicle consisting of Ora-Plus and Ora-Sweet (Perrigo) over a period of 90 days. Three replicate test preparations were stored at room temperature or refrigerated at 4.3–5.2 °C, and samples were analyzed in duplicate immediately after preparation and on study days 1, 2, 4, 7, 10, 14, 21, 30, 48, 60, 75, and 90. Results The 2-mg/mL suspension of pyrimethamine in Ora-Plus and Ora-Sweet retained 90–110% of the labeled potency to 90 days at both temperature ranges. However, color changes in the samples stored at room temperature observed at day 60 indicated that a beyond-use date less than 90 days from the preparation date should be specified when the suspension is to be stored at room temperature. Conclusion The study demonstrated that USP-grade pyrimethamine powder can be formulated as a 2-mg/mL suspension in a vehicle of Ora-Plus and Ora-Sweet and is stable when stored at room temperature and when refrigerated, in amber plastic bottles, for 48 and 90 days, respectively.

scholarly journals Stability of extemporaneously compounded amiloride nasal spray

2020 ◽  
Author(s):  
Venkata Yellepeddi ◽  
Casey Sayre ◽  
Anna Burrows ◽  
Kevin Watt ◽  
Simon Davies ◽  
...  
Keyword(s):  
United States ◽  
Nasal Spray ◽  
Room Temperature ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Indicating ◽  
Spray Solution ◽  
Microbiological Stability ◽  
The Stability ◽  
Amiloride Hydrochloride

AbstractAnxiety disorders (AD) are the most common mental illnesses affecting an estimated 40 million adults in the United States. Amiloride, a diuretic agent, has shown efficacy in treating AD in preclinical models by inhibiting the acid-sensing ion channels (ASIC). By delivering amiloride via nasal route, rapid onset of action can be achieved due to direct “nose-to-brain” access. Therefore, this study reports the formulation, physical, chemical, and microbiological stability of an extemporaneously prepared amiloride 2 mg/mL nasal spray. The amiloride nasal spray was prepared by adding 100 mg of amiloride hydrochloride to 50 mL of sterile water for injection in a sterile reagent bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated. Forced-degradation studies were performed to confirm the ability of the HPLC method to identify the degradation products from amiloride distinctively. The physical stability of the amiloride nasal spray was assessed by pH, clarity, and viscosity assessments. For chemical stability studies, samples of nasal sprays stored at room temperature were collected at time-points 0, 3 hr., 24 hr., and 7 days and were assayed in triplicate using the stability-indicating HPLC method. Microbiological stability of the nasal spray solution was evaluated for up to 7 days based on the sterility test outlined in United States Pharmacopoeia (USP) chapter 71. The stability-indicting HPLC method identified the degradation products of amiloride without interference from amiloride. All tested solutions retained over 90% of the initial amiloride concentration for the 7-day study period. There were no changes in color, pH, and viscosity in any sample. The nasal spray solutions were sterile for up to 7 days in all samples tested. An extemporaneously prepared nasal spray solution of amiloride hydrochloride (2 mg/mL) was physically, chemically, and microbiologically stable for 7 days when stored at room temperature.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR STABILITY INDICATING HPTLC METHOD FOR ASSAY OF STIRIPENTOL IN BULK AND DOSAGE FORM

2021 ◽  
Vol 3 (4) ◽  
pp. 26-30
Author(s):  
Santosh Kumar Kashid ◽  
Amit Tapkir ◽  
Pravin Choudhari
Keyword(s):  
Room Temperature ◽  
Method Development ◽  
Limit Of Detection ◽  
Acidic Condition ◽  
Calibration Plot ◽  
Stability Indicating ◽  
Study Results ◽  
Limit Of Quantitation ◽  
Method Development And Validation ◽  
Development And Validation

Introduction: This work is concerned with the stability-indicating method development and validation of Stiripentol in a bulk drug and formulation by high-performance thin-layer chromatographic method (HPTLC). Materials and Methods:The pre-coated silica gel 60 F254 aluminum plate was selected as the stationary phase, and the solvent system consisted of Ethyl acetate: Dichloromethane: Toluene (2:2:6 v/v) used as developing solvents. Analysis of Stiripentol was carried out at 301 nm with Stiripentol being detected at an R(f) of 0.63. The developed method was validated for linearity, accuracy, precision, limit of detection (LoD), limit of quantitation (LoQ), robustness parameters, and stability are determined by force degradation study. Results and Discussion: The correlation coefficient of Stiripentol was 0.994 observed. The calibration plot was linear between 50–300 ng/band, respectively. The average percentage recovery of Stiripentol was found to be 100.25 %. Intra and inter-day precision measured as %RSD was less than 2%. Hence stability study of Stiripentol, it was found to degrade in acidic condition(8.52% - 0.1N HCL for 30 minutes at room temperature), alkali condition(7.47%- 0.1 N NaOH for 30min at room temperature), Hydrolytic condition(4.73%– dist. Water for 30min at room temperature), thermal condition(7.69%-40°C for 30min ), oxidative condition(7.55% - 3% H2O2 for 30min at room temperature) and photolytic UV condition(7.54% -24hr UV radiation) respectively. Stiripentol was unstable in acidic condition and stable in normal dist. Water hydrolytic condition. Conclusion: The proposed method was found to be very sensitive and accurate for the determination of Stiripentol in bulk and formulation.

Stability of Caffeine Injection in Intravenous Admixtures and Parenteral Nutrition Solutions

DICP ◽  
1989 ◽  
Vol 23 (6) ◽  
pp. 466-467 ◽  
Author(s):  
Milap C. Nahata ◽  
Josephine R. Zingarelli ◽  
Diane E. Durrell
Keyword(s):  
Amino Acids ◽  
Parenteral Nutrition ◽  
Potassium Chloride ◽  
Room Temperature ◽  
Hplc Method ◽  
Final Concentration ◽  
Stability Indicating ◽  
The Stability

Our objective was to determine the stability of caffeine base in intravenous admixtures and parenteral nutrition solutions at room temperature for 24 hours. Caffeine 10 mg/mL was used in this study. The admixtures included D5W; D5W with NaCl 0.2% injection; D5W with NaCl 0.2% and 20 mEq/L of potassium chloride injection; D10W injection; and D10W with NaCl 0.2% and 5 mEq/L of KCl injection. The parenteral nutrition solutions included 1.1% amino acids with electrolytes; 2.2% amino acids with electrolytes; and 4.25% amino acids with electrolytes. These parenteral nutrition solutions were prepared in D10W. Ten milliliters of caffeine were added to glass test tubes containing 10 mL of various solutions to yield a final concentration of 5 mg/mL. One milliliter aliquots were removed at 0, 2, 4, 8, and 24 hours and caffeine was measured by a stability-indicating HPLC method. The largest change in the concentrations of caffeine was 4.1 percent during the study period. Thus, caffeine injection is stable in various admixtures and parenteral nutrition solutions at room temperature for 24 hours.

Stability of Famotidine in Polyvinyl Chloride Minibags and Polypropylene Syringes and Compatibility of Famotidine with Selected Drugs

1993 ◽  
Vol 27 (4) ◽  
pp. 422-426 ◽  
Author(s):  
Xu Keyi ◽  
Nancy Gagnon ◽  
Chantal Bisson ◽  
Marc Desmarais ◽  
Marc LeBel
Keyword(s):  
Polyvinyl Chloride ◽  
Room Temperature ◽  
Time Intervals ◽  
Ph Changes ◽  
Stability Indicating ◽  
The Stability

OBJECTIVE: (1) To determine the stability of famotidine 200 μg/mL in admixtures with dextrose 5% injection (D5W) and NaCl 0.9% injection (NS) in polyvinyl chloride (PVC) minibags and polypropylene syringes, at room temperature (22 °C), protected and unprotected from light for 15 days; and (2) to evaluate the visual compatibility of famotidine with 34 selected drugs for four hours at room temperature. DESIGN: Concentration of famotidine samples was determined on day 0 and again on days 3, 6, 9, 12, and 15 by a stability-indicating HPLC. Inspection for visual and pH changes was also performed at these time intervals. RESULTS: More than 95 percent of the day 0 famotidine concentration remained in all samples over the 15-day study period. During this period, all samples remained clear and colorless and no change in absorbance at 450 and 540 nm was observed. The pH of the samples also remained unchanged. Famotidine 2000 μg/mL was found to be compatible with 33 selected drugs; only furosemide was found to be incompatible. A white precipitate was observed when an equal volume of famotidine 2000 μg/mL in NS was mixed with furosemide 3000 μg/mL in D5W. The concentration of famotidine in the supernatant gradually decreased during the 4-hour study period. At 0.5, 1.0, 2.0, and 4.0 hours after mixture of famotidine with furosemide, famotidine concentrations were 97.5, 23.6, 21.7, and 17.2 percent of the initial famotidine concentration, respectively. CONCLUSIONS: Our results show that famotidine 200 μg/mL was stable in admixture with D5W and NS in PVC minibags and polypropylene syringes when these solutions were stored at room temperature, protected and unprotected from light for 15 days. Famotidine 2000 μg/mL in NS was compatible with 33 of the drugs, and was incompatible with furosemide.

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