scholarly journals STABILITY STUDY OF AMLODIPINE BESYLATE AND BISOPROLOL FUMARATE IN AQUEOUS SOLUTIONS

2014 ◽  
Vol 5 (2) ◽  
Author(s):  
Irena Kasagić Vujanović ◽  
Dijana Jelić ◽  
Vesna Antunović ◽  
Biljana Jančić Stojanović ◽  
Darko Ivanović
Keyword(s):  
Relevant Information ◽  
Pharmaceutical Product ◽  
Stability Study ◽  
Amlodipine Besylate ◽  
Time Intervals ◽  
Constant Rate ◽  
Different Temperatures ◽  
The Media ◽  
Two Temperatures ◽  
The Stability

Valuable information concerning stability of compounds can be obtained by using different media (water, hydrochloric acid or sodium hydroxide) for dissolution of active pharmaceutical substances. Furthermore, additional knowledge is gained by performing experiments at different temperatures. This research paper deals with the stability of amlodipine besylate and bisoprolol fumarate in different media at different temperatures, whereby certain conclusions are drawn. For stability assessment, chemical kinetics approach was used, and constant rate (k), half-time (t1/2) and activation energy (Ea) were used for prediction of compound stability degree. The stability of amlodipine besylate and bisoprolol fumarate were tested, both separately and in mixture, in water and in 0.01M HCl. All the investigated solutions were treated at two temperatures 25° and 70°C at the following time intervals: 0, 1 h, 24 h, 48 h and 72 h. Hydrophilic Interaction Liquid Chromatography – HILIC method, previously developed and validated, was used. On the basis of obtained results it was concluded that amlodipine-besylate was more stable in water than in acid medium, more stable in mixture rather than individually and more stable at lower temperatures. This was confirmed by the obtained values of monitored parameters: amlodipine besylate Ea = 30.68 kJ mol-1, k (25 °C) = 0.000333 mM h-1, k (70 °C) = 0.00169 mM h-1; amlodipine besylate in mixture Ea = 42,414 kJ mol-1, k (25 °C) = 1.27∙10-4 mM h-1, k (70 °C) = 0.0012 mM h-1. Based on the obtained approximate Ea value for bisoprolol fumarate in acid (59 kJ mol-1) and in water (56 kJ mol-1), bisoprolol fumarate showed excellent stability against the media in which it was studied. On the other hand, the temperature had a significant effect on the stability of bisoprolol fumarate. These results provide the relevant information about the stability of the tested active substances, and may be of importance during the development of an appropriate pharmaceutical product. A bigger influence on the stability of bisoprolol fumarate had a temperature effect.

Stability Study of fast Disintegrating tablets of Nisoldipine as per ICH Guidelines

2021 ◽  
pp. 5843-5844
Author(s):  
Seema Saini ◽  
Rajeev Garg
Keyword(s):  
Research Work ◽  
Storage Period ◽  
Pharmaceutical Product ◽  
Stability Study ◽  
Disintegration Time ◽  
Drug Content ◽  
Ich Guidelines ◽  
Significant Difference ◽  
Fast Disintegrating Tablet ◽  
The Stability

The stability study is a critical parameter to be evaluated in a pharmaceutical product development cycle. A pharmaceutical scientist pays a great deal of heed in testing a product stability. The present research work focused on conducting stability study of fast disintegrating tablet batch of Nisoldipine (NFDT). The various parameters evaluated were weight, hardness, friability, disintegration time, drug content and % drug released. The stability study of optimized fast disintegrating tablet batch NFDT was performed according to ICH guidelines. For the study plan, fast disintegrating tablet batch was placed in a wide mouth air tight containers, which were charged into the stability chamber. The temperature was adjusted at 40°C ± 2°C and relative humidity of 75% ± 5%. The study period was of 6 months. The fast disintegrating tablet batch NFDT did not showed any significant difference in weight, hardness, % friability and disintegration time. The drug content was also reported to be in limits of acceptance. The % drug released at various time intervals was insignificantly changed during its storage period. Hence, the prepared tablets were stable during their storage period.

Solvent Effect of Oxygen in the Thermolisys Decomposition of the Acetone Diperoxide

2011 ◽  
Vol 1 (1) ◽  
pp. 96-102 ◽  
Author(s):  
M. I. Profeta ◽  
J. R. Romero ◽  
L. A. C. Leiva ◽  
N. L. Jorge ◽  
M. E. Gomez Vara ◽  
...  
Keyword(s):  
Decomposition Reaction ◽  
Bond Rupture ◽  
Isokinetic Temperature ◽  
Isokinetic Relationship ◽  
Linear Relationships ◽  
Different Temperatures ◽  
Entropy Of Activation ◽  
The Media ◽  
Two Temperatures ◽  
Effect Of Oxygen

In this paper, the kinetics of the thermal decomposition reaction of 3,3,6,6-tetramethyl-1,2,4,5 tetroxane (ACDP) is investigated in various oxygen solvents at different temperatures. Linear relationships are observed between the enthalpy and entropy of activation of the unimolecular reactions of those diperoxides. The isokinetic temperature calculated by Leffler’s treatment is 527.2K, which is consistent with the proposed Exner correlation between the logarithm of the rate constant values for the same reaction in each solvent at two temperatures, where the corresponding ß value was 523.5K. A true “isokinetic relationship” for the ACDP thermolysis indicates that their reactions constitute a reaction series with similar interaction mechanisms. This can be related to the capacity for hydrogen bonding between the solvent and the diperoxide molecules. The solvanting properties of the media help the peroxidic bond rupture these molecules.

The Stability Study of Thermodynamic Parameters of Sorption of Light Hydrocarbons on Poly [Trimethylsilyl (Propyn-1)] at Different Temperatures

2019 ◽  
Vol 57 (9) ◽  
pp. 778-783
Author(s):  
V E Shiryaeva ◽  
A A Korolev ◽  
T P Popova ◽  
A Y Kanateva ◽  
A A Kurganov
Keyword(s):  
Stationary Phase ◽  
Thermodynamic Parameters ◽  
Heating Temperature ◽  
Chromatographic Determination ◽  
Stability Study ◽  
Light Hydrocarbons ◽  
Different Temperatures ◽  
Entropy Factor ◽  
The Stability

Abstract Chromatographic determination of the thermodynamic parameters of sorption for light hydrocarbons retention on a stationary phase based on poly [trimethylsilyl (propyn-1)] (PTMSP) was performed and the effect of column preheating at temperatures up to 260°C on the retention of analytes was investigated. It was shown that heating the column to 130°C does not affect the retention of the analytes. At temperatures above 130°C, the gradual decrease of the retention of analytes on PTMSP stationary phase is observed. The process is non-selective and proceeds at the same extent for all the studied hydrocarbons, regardless of the size and geometry of the molecule. Values of enthalpy and entropy of sorption of light hydrocarbons are determined for the original column and after its aging at 200°C. The enthalpy of sorption of the analytes at the PTMSP phase is practically independent on the heating temperature of the PTMSP phase, whereas the loss of entropy increases after heating. The increase of the entropy factor after the heating of the PTMSP stationary phase is associated with its aging and is confirmed by the construction of compensation functions for treated and untreated columns.

scholarly journals Stability Study of an Electrothermally-Actuated MEMS Mirror with Al/SiO2 Bimorphs

Micromachines ◽  
2019 ◽  
Vol 10 (10) ◽  
pp. 693 ◽  
Author(s):  
Peng Wang ◽  
YaBing Liu ◽  
Donglin Wang ◽  
Huan Liu ◽  
Weiguo Liu ◽  
...  
Keyword(s):  
Fill Factor ◽  
Microelectromechanical Systems ◽  
Stability Study ◽  
Driving Voltage ◽  
Electrothermal Actuation ◽  
Different Temperatures ◽  
Dynamic Scan ◽  
Bimorph Actuators ◽  
The Stability

Electrothermal actuation is one of the main actuation mechanisms and has been employed to make scanning microelectromechanical systems (MEMS) mirrors with large scan range, high fill factor, and low driving voltage, but there exist long-term drifting issues in electrothermal bimorph actuators whose causes are not well understood. In this paper, the stability of an Al / SiO 2 bimorph electrothermal MEMS mirror operated in both static and dynamic scan mode has been studied. Particularly, the angular drifts of the MEMS mirror plate were measured over 90 h at different temperatures in the range of 50 – 150 °C. The experiments show that the temporal drift of the mirror plate orientation largely depends on the temperature of the electrothermal bimorph actuators. Interestingly, it is found that the angular drift changes from falling to rising as the temperature increases. An optimal operating temperature between 75 °C to 100 °C for the MEMS mirror is identified. At this temperature, the MEMS mirror exhibited stable scanning with an angular drift of less than 0.0001 °/h.

scholarly journals Prefilled Cyclic Olefin Sterilized Syringes of Norepinephrine Injection Solution Do Not Need to Be Stabilized by Antioxidants

2020 ◽  
Vol 21 (7) ◽  
Author(s):  
Karin H. M. Larmené- Beld ◽  
Stefan van Berkel ◽  
Rommert Wijnsma ◽  
Katja Taxis ◽  
Henderik W. Frijlink
Keyword(s):  
Ascorbic Acid ◽  
Stability Study ◽  
Sodium Metabisulfite ◽  
Test Results ◽  
Time Intervals ◽  
Cyclic Olefin ◽  
Sympathomimetic Drug ◽  
Norepinephrine Concentration ◽  
The Stability ◽  
New Formulation

Abstract Norepinephrine is a potent α-sympathomimetic drug which plays an important role in the acute treatment of hypotension and shock. Commercially available norepinephrine solutions contain sodium metabisulfite (Na2S2O5) as an antioxidant. However, prefilled cyclic olefin polymer syringes are not compatible with sodium metabisulfite. The aim of this study was to develop a new formulation of 0.1-mg/mL norepinephrine solution without sodium metabisulfite which is chemically stable and sterile and can be stored in prefilled polymer syringes. Formulation studies were performed with 0.1-mg/mL norepinephrine solution with 0, 0.05, or 0.1% ascorbic acid added as antioxidant. The syringes were filled under nitrogen gassing, stored at 20 ± 5°C, and protected from daylight. Based on the formulation test results, the final formulation was defined and stability testing at 20 ± 5°C was performed measuring norepinephrine concentration, pH, clarity, color of the solution, subvisible particles, and sterility at time intervals up to 12 months. The norepinephrine concentrations at t = 22 weeks were 100.4%, 95.4%, and 92.2% for the formulations with no ascorbic acid and with 0.05% and 0.10% ascorbic acid, respectively. Three batches for the stability study were produced containing norepinephrine, sodium edetate, sodium chloride, and water for injections filled under nitrogen gassing and stored at 20 ± 5°C. Norepinephrine concentrations were respectively 98.8%, 98.6%, and 99.3% for batches 1, 2, and 3 at t = 12 months. It can be concluded that norepinephrine (0.1 mg/mL) solution without metabisulfite is stable for at least 12 months at room temperature when protected from daylight.

scholarly journals DEVELOPMENT OF NANOEMULSION CONTAINING PELARGONIUM GRAVEOLENS OIL: CHARACTERIZATION AND STABILITY STUDY

2016 ◽  
Vol 8 (12) ◽  
pp. 271 ◽  
Author(s):  
Janice Luehring Giongo ◽  
Rodrigo De Almeida Vaucher ◽  
Aline Ourique ◽  
MÍriam Steffler ◽  
Clarissa Piccinin Frizzo ◽  
...  
Keyword(s):  
Particle Size ◽  
Storage Temperature ◽  
Thermo Gravimetric Analysis ◽  
Physicochemical Characteristics ◽  
Stability Study ◽  
Gas Chromatography Mass Spectrometry ◽  
Gravimetric Analysis ◽  
Scanning Calorimetry ◽  
Different Temperatures ◽  
The Stability

<p><strong>Objective: </strong>To develop, characterize and evaluate the stability of nanoemulsions containing geranium oil (NEG) at different temperatures (4 °C, 25 °C and 45 °C) for 90 d.</p><p><strong>Methods: </strong>The quantification of oil in the nanostructure was performed by <a href="https://www.google.com.br/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=1&amp;cad=rja&amp;uact=8&amp;ved=0ahUKEwiYjL3Niv7OAhVJI5AKHZ-_AeUQFggfMAA&amp;url=https%3A%2F%2Fen.wikipedia.org%2Fwiki%2FGas_chromatography%25E2%2580%2593mass_spectrometry&amp;usg=AFQjCNE3N9EyqMTXtw7u0lxolSlnU5zJfQ">gas chromatography–mass spectrometry</a> (GC-MS). The NEG was prepared in Ultra-Turrex and characterized by determining the particle size, polydispersity indices and pH. The thermo gravimetric analysis (TGA), differential scanning calorimetry (DSC) and transmission electron microscopy (TEM) to evaluate the thermal stability of the compounds, the thermal events and morphological analyses of NEG, respectively.<strong></strong></p><p><strong>Results: </strong>The results allow us to suggest that the use the ultra-turrax method is a strategy good to NEG preparation. The stability of the NEG was strongly influenced by storage temperature, with droplet size increasing rapidly at higher temperatures (45 °C), which was attributed to coalescence near the phase inversion temperature. The NEG submitted the low temperatures (4±2 °C) remained with the same particle size value (164 nm). However, the citronellol and geraniol showed a significant reduction throughout the test even in these conditions of temperature. Thermogram of NEG shows the crystallization peak at the cooling cycle in-20.1 °C and a melting was observed at 1.5 °C. TEM images indicated that NEG was spherical and nanometric.</p><p><strong>Conclusion: </strong>The proposed Ultra-Turrax method is simple which prevents volatilization of GO for the production of NEG. The formulations presented good physicochemical characteristics and stability for 90 d was only achieved in 4 °C.</p>

Stability Study of Epirubicin in Nacl 0.9% Injection

1997 ◽  
Vol 31 (9) ◽  
pp. 992-995 ◽  
Author(s):  
Montserrat Pujol ◽  
Montserrat Muñoz ◽  
Josefina Prat ◽  
Victoria Girona ◽  
Jordi De Bolós
Keyword(s):  
Shelf Life ◽  
Room Temperature ◽  
Degradation Kinetics ◽  
Storage Conditions ◽  
Hplc Method ◽  
Stability Study ◽  
Chemistry Laboratory ◽  
Maximum Decrease ◽  
Different Temperatures ◽  
The Stability

Objective To determine the stability of epirubicin in NaCl 0.9% injection under hospital storage conditions. Methods NaCl 0.9% solution was added to epirubicin iyophilized powder to make a final concentration of 1 mg/mL to study the degradation kinetics and 2 mg/mL to study the stability in polypropylene syringes under hospital conditions. Setting Physical chemistry laboratory, Unitat de Fisicoquímica, Universitat de Barcelona. Main outcome Measures Solutions of epirubicin at 2 mg/mL in NaCl 0.9% solutions stored in plastic syringes were studied under hospital conditions at room temperature (25 ± 1 °C) and under refrigeration (4 ± 1 °C) both protected from light and exposed to room light (~50 lumens/m2). All samples were studied in triplicate and epirubicin concentrations were obtained periodically throughout each storage/time condition via a specific stability-indicating HPLC method. To determine the degradation kinetics, solutions of epirubicin in NaCl 0.9% at 1 mg/mL were stored at different temperatures (40, 50, and 60 °C) to obtain the rate degradation constant and the shelf life at room temperature and under refrigeration. Results The degradation of epirubicin in NaCl 0.9% solutions follows first-order kinetics. The shelf life was defined as the time by which the epirubicin concentration had decreased by 10% from the initial concentration. In this study, epirubicin was stable in NaCl 0.9% injection stored in polypropylene containers for all time periods and all conditions. That results in a shelf life of at least 14 and 180 days at 25 and 4 °C, respectively. The maximum decrease in epirubicin concentration observed at 25 °C and 14 days was 4%, and at 4 °C and 180 days was 8%. The predicted shelf life obtained from the Arrhenius equation was 72.9 ± 0.2 and 3070 ± 15 days at 25 and 4 °C, respectively, in both dark and illuminated conditions. Conclusions Solutions of epirubicin in NaCl 0.9% at 2 mg/mL are chemically stable when they are stored in polypropylene syringes under hospital storage conditions. No special precaution is neccessary to protect epirubicin solutions (2 mg/mL) from light.

scholarly journals Stability of Antibiotics for Intraperitoneal Administration in Extraneal 7.5% Icodextrin Peritoneal Dialysis Bags (Stab Study)

2016 ◽  
Vol 36 (4) ◽  
pp. 421-426 ◽  
Author(s):  
Dwarakanathan Ranganathan ◽  
Saiyuri Naicker ◽  
Steven C. Wallis ◽  
Jeffrey Lipman ◽  
Sharad K. Ratanjee ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Room Temperature ◽  
Intraperitoneal Administration ◽  
Stability Studies ◽  
Initial Value ◽  
Time Intervals ◽  
Storage Duration ◽  
Different Temperatures ◽  
The Stability ◽  
Drug Free

Background and objectivesPatients with peritoneal dialysis (PD)-associated peritonitis may be advised to store PD-bags with pre-mixed antibiotics at home, although there is a paucity of antibiotic stability studies in the commonly used icodextrin solutions. The purpose of this study was to assess the stability of various antibiotics in PD-bags when stored at different temperatures over a 14-day period.Methods7.5% icodextrin PD-bags were dosed with gentamicin 20 mg/L ( n = 9), vancomycin 1,000 mg/L ( n = 9), cefazolin 500 mg/L ( n = 9) and ceftazidime 500 mg/L ( n = 9) as for intermittent dosing. Combinations of gentamicin/vancomycin ( n = 9), cefazolin/ceftazidime ( n = 9), and cefazolin/gentamicin ( n = 9) were also tested. Nine drug-free bags were used as controls. Bags were stored in triplicate at 37°C, room-temperature (25°C), and refrigeration (4°C). Antibiotic concentrations were quantified at various time intervals using validated chromatography. Storage duration was considered unstable if the concentration of the antibiotic dropped ≤ 90% of the initial value.ResultsGentamicin was stable for 14 days at all temperatures. Vancomycin was stable for 4 days at 37°C and for 14 days at both 25°C and 4°C. The gentamicin and vancomycin combination was stable for 4 days at 37°C and for 14 days at 25°C and 4°C. Cefazolin alone was stable for 24 hours at 37°C, 7 days at 25°C, and 14 days at 4°C. Ceftazidime alone was stable for only 6 hours at 37°C, 2 days at 25°C, and 14 days at 4°C. The cefazolin and ceftazidime combination was stable for 24 hours at 37°C, 2 days at 25°C, and 14 days at 4°C. The cefazolin and gentamicin combination was stable for 1 day at 37°C, 4 days at 25°C, and 14 days at 4°C.ConclusionsAntibiotics premixed in icodextrin PD-bags have varying stabilities with stability generally least at 37°C and best at 4oC, permitting storage for 14 days when refrigerated and pre-warming to body temperature prior to administration. Further research confirming the sterility of these antibiotic-containing bags is recommended.

scholarly journals Stability study of Laghusutashekhara Rasa Tablets - With Respect to Baseline Microbial Diagnostic Modalities

2020 ◽  
Vol 11 (3) ◽  
pp. 466-469
Author(s):  
Ashvinee Vasava ◽  
Meera Cholera ◽  
Shubhangi Kamble
Keyword(s):  
Microbial Contamination ◽  
Climatic Conditions ◽  
Stability Study ◽  
Time Intervals ◽  
Traditional Medicines ◽  
Microbiological Study ◽  
Regular Time ◽  
Diagnostic Modalities ◽  
The Stability ◽  
Micro Organisms

Background: In last a few decades, market of herbal, herbo-mineral and traditional medicines have grown up leap and bound. The main drawback of traditional medicines is lack of stability. Hence the present study was carried out to observe the stability of Laghusutashekhara Rasa tablet with respect to its stability against microbial contamination of sample prepared and stored in different climatic conditions and temperature. Aim: To study the stability of Laghusutashekhara Rasa tablet and to check microbial contamination in the finished product at different time intervals, at different climatic conditions, temperature and humidity set ups. Materials and Methods: Sample of Laghusutashekhara Rasa tablet was studied to check microbial contamination at different climatic conditions. The study was conducted at Microbiology Laboratory, IPGT & RA, Jamnagar, Gujarat, India. Observations & Results: The initial microbiological study was done to rule out stability of prepared drug up to first consumption of the same. The study of Laghusutashekhara Rasa tablet was done on 3rd day of preparation, before giving to the patients i.e. first day of drug consumption after preparation of drug. Then further study was carried out at regular time intervals up to 220 days. Conclusion: In microbiological study of Laghusutashekhara Rasa tablet, growth of micro-organisms (bacterial or fungal) was not found till 10th February, 2020 from the date of preparation, which shows its stability and good shelf life. Hence in present study the stability test of Laghusutashekhara Rasa tablet with respect to microbiological findings was negative at room temperature, warm and cold, dry and humid conditions.

scholarly journals Derivative Spectrophotometric Methods for the Analysis and Stability Studies of Colistin Sulphate

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Mohammed Mutasim Elimam ◽  
Shaza Wagiealla Shantier ◽  
Elrasheed Ahmed Gadkariem ◽  
Magdi Awadalla Mohamed
Keyword(s):  
Stability Study ◽  
Alkaline Media ◽  
Second Derivative ◽  
Spectrophotometric Methods ◽  
Different Temperatures ◽  
The Stability ◽  
Second Derivative Spectra ◽  
Rate Profile ◽  
Second Derivative Method

Simple spectrophotometric methods were developed for the quantitative determination of colistin sulphate in bulk and dosage forms. The methods were based on the measurement of first and second derivative spectra of colistin sulphate at 298 nm and 318 nm, respectively. Beer’s law was obeyed in the concentration range 800–4000 IU/mL with good correlation coefficient (not less than 0.998) for both methods. The developed first derivative spectrophotometric method was then selected to study the degradation behavior of colistin sulphate in alkaline media at different temperatures as the second derivative method failed to give reproducible results for the stability study. The pH-rate profile indicates a first-order dependence of the degradation rate on [OH−] at pH ranging between 8 and 11. The obtained results for the photochemical study reflected photostability of colistin sulphate.

Sign in / Sign up

Export Citation Format

Share Document