Validation of UV-Vis Spectrophotometric Method for Stability Evaluation of 5% Extemporaneous Vancomycin Eye Drops in Various Vehicles

2020 ◽  
Vol 859 ◽  
pp. 277-282
Author(s):  
Danuch Panchapornpon ◽  
Sirikarn Pengon ◽  
Nawinda Chinatangkul ◽  
Terachart Chevadisaikul

UV-Vis spectrophotometric method was validated for the stability assessment of 5% extemporaneous vancomycin eye drops in different vehicles. The eye drops were extemporaneously prepared by dissolving vancomycin in various vehicles, including sterile water for injection (SWI), 0.45% normal saline (0.45%NSS) and artificial tear. The solutions were stored at room temperature and in refrigerator for 30 days. The content of vancomycin was measured by UV-Vis spectrophotometer at 280 nm. UV-Vis Spectrophotometric method was validated according to ICH guideline. The results indicated that the method was precise and accurate. The calibration curve was linear with r2 = 0.9997 in the range of 40-160 μg/mL. LOD and LOQ were 3.39 and 10.26 μg/mL, respectively. The results showed that the percentage of vancomycin residual concentation in SWI and 0.45%NSS was decreased to less than 90% after storage at room temperature for 8 days, whereas the residual concentration of vancomycin in artificial tear was less than 90 % after 10 days in room temperature. Meanwhile the percentage of vancomycin residual concentation in all formulations was remarkably decreased to less than 90% after storage in refrigerator for 17 days. The physical appearance of eye drops in artificial tear remained unchanged. However the observed color of other formulations was gradually changed to yellow in day 7 at room temperature and day 17 in refrigerator. The pH values of all preparations were within the general U.S. pharmacopeia national formulation range of 2.5-4.5. In conclusion, the eye preparations of 5%w/v vancomycin in all selected vehicle were stable for 17 days in refrigerator (2-8°C).

Author(s):  
SRI AGUNG FITRI KUSUMA ◽  
MARLINE ABDASSAH

Objective: The purpose of this study was to determine a sterile 0.5% chloramphenicol eye drop formula with the best potency of antibacterial by determining the appropriate sterilization method and the supporting pH. Methods: 0.5% chloramphenicol was formulated with 0.01% thimerosal, which act as a bactericide and combines with borate buffer to produce eye drop formulas with variations in pH (6.8, 7.0 and 7.4). All formulas were stored at room temperature for 28 d and were evaluated, including: organoleptic of the preparations, sterility, pH stability, and the antibacterial potency of chloramphenicol in eye drops. Results: All dosage formulas did not undergo photodegradation reactions which were marked by no change in color until the end of the storage period. However, the formula with pH 6.8 which was sterilized by heating in a presence of bactericide, showed the presence of more particulate precipitates than in the pH 6.8 formula which was sterilized using membrane filter bacteria. However, both methods of sterilization produced sterile chloramphenicol eye drops. The preparation using a method of heat sterilization with bactericide decreased the pH greater than the preparation using a sterile bacterial filter sterilization method. C2 preparations at pH 7.0 and sterilized using the bacterial filter membrane sterilization method were more stable because they had the smallest pH change of 0.05 and the percentage reduction in antibacterial potential was smaller at 1.15%. Conclusion: The best treatment for the chloramphenicol eye drop was kept the pH formula at pH 7 and sterilized using bacterial filter membrane sterilization method.


2007 ◽  
Vol 31 (1) ◽  
pp. 55-61
Author(s):  
Lubna Ahmed Al-Ani

The effect of temperature and pH on the stability of the antibacterial“tilmicosin” was evaluated in this study. The temperature degrees studied were25 , 45 and 65 oC each for 24 hours , while the pH values studied were 6 , 7 and8 each at room temperature and for 24 hours also.A microbiological assay method was employed for analysis of the collectedsamples.The results of analysis indicate significant drop in activity of the drug as aresults of exposure to temperature or pH.The above mentioned results necessitate the maintenance of drinking water inthe storage depots of the field below 65 oC especially in summer season, so tokeep the chemical structure of the drug and to offer enough therapeuticconcentration to reach the tissue.


1968 ◽  
Vol 14 (2) ◽  
pp. 147-151
Author(s):  
Cvetka M. Jakus ◽  
Lyn McClure ◽  
A. C. Wardlaw

Pertussis sonic lysates were adjusted to a series of pH values between 3.0 and 11.0, held for 1 hour at room temperature, and then returned to neutrality and assayed for residual mouse protective antigen (MPA) and histamine-sensitizing factor (HSF) activities. The percentage in-activation of MPA at pH 3.0, 10.0, and 11.0 was respectively 30, 18, and 40 but only the last value is significantly different from the pH 7.2 control. The percentage inactivation of HSF in the same samples was 40, 29, and 75 respectively. Exposure to pH 11.0 had a significantly greater destructive effect on HSF than on MPA.These data may be of future value in helping to develop methods for purifying MPA, for they indicate that this factor is reasonably stable to pH within a usefully wide range.


1961 ◽  
Vol 06 (03) ◽  
pp. 435-444 ◽  
Author(s):  
Ricardo H. Landaburu ◽  
Walter H. Seegers

SummaryAn attempt was made to obtain Ac-globulin from bovine plasma. The concentrates contain mostly protein, and phosphorus is also present. The stability characteristics vary from one preparation to another, but in general there was no loss before 1 month in a deep freeze or before 1 week in an icebox, or before 5 hours at room temperature. Reducing agents destroy the activity rapidly. S-acetylmercaptosuccinic anhydride is an effective stabilizing agent. Greatest stability was at pH 6.0.In the purification bovine plasma is adsorbed with barium carbonate and diluted 6-fold with water. Protein is removed at pH 6.0 and the Ac-globulin is precipitated at pH 5.0. Rivanol and alcohol fractionation is followed by chromatography on Amberlite IRC-50 or DEAE-cellulose. The final product is obtained by isoelectric precipitation.


Author(s):  
Potdar S. S. ◽  
Karajgi S. R. ◽  
Simpi C. C. ◽  
Kalyane N. V.

The spectrophotometric method for estimation of CefpodoximeProxetil employed first derivative amplitude UV spectrophotometric method for analysis using methanol as solvent for the drug. CefpodoximeProxetil has absorbance maxima at 235nm and obeys Beer’s law in concentration range 10-50µg/ml with good linearity i.e. r2 about 0.999. The recovery studies established accuracy of the proposed method; result validated according to ICH guideline. Results were found satisfactory and reproducible. The method was successfully for evaluation of CefpodoximeProxetil in tablet dosage form without interference of common excipients.


2020 ◽  
Author(s):  
Katsuya Maruyama ◽  
Takashi Ishiyama ◽  
Yohei Seki ◽  
Kounosuke Oisaki ◽  
Motomu Kanai

A novel Tyr-selective protein bioconjugation using the water-soluble persistent iminoxyl radical is described. The conjugation proceeded with high Tyr-selectivity and short reaction time under biocompatible conditions (room temperature in buffered media under air). The stability of the conjugates was tunable depending on the steric hindrance of iminoxyl. The presence of sodium ascorbate and/or light irradiation promoted traceless deconjugation, restoring the native Tyr structure. The method is applied to the synthesis of a protein-dye conjugate and further derivatization to azobenzene-modified peptides.


1987 ◽  
Vol 52 (5) ◽  
pp. 1356-1361
Author(s):  
S. Abdel Rahman ◽  
M. Elsafty ◽  
A. Hattaba

The conformation of elastin-like peptides Boc-Ala-Pro-Gly-Val-APEGM, Boc-Ala-Pro-Gly-Val-Gly-Val-APEGM, Boc-Ala-Pro-Gly-Val-Ala-Pro-Gly-Val-Gly-Val-APEGM, Boc-Ala-Pro-Gly-Val-Gly-Val-Ala-Pro-Gly-Val-Gly-Val-APEGM were examined in solution using circular dichroism at 30 °C, 50 °C, and 70 °C and in solid state by IR at room temperature. The studies show that the β-turn is a significant conformational feature for peptides under investigation in solution at 30 °C and 50 °C, but at 70 °C the tetra, hexa, and decapeptides show the CD feature characteristic of the β-structure while the dodecapeptide spectra show the presence of β-turn which indicates the stability of the β-turn at this chain length. The IR spectra show that in the solid state at room temperature all investigated peptides assume essentially a β-turn except the tetrapeptide which present evidence of antiparallel β-structure. The β-turn contribution in the IR spectra increases with the increase of the chain length of the peptide.


1956 ◽  
Vol 2 (3) ◽  
pp. 145-159 ◽  
Author(s):  
Joseph T Anderson ◽  
Ancel Keys

Abstract 1. Methods are described for the separation, by paper electrophoresis and by cold ethanol, of α- and β-lipoproteins in 0.1 ml. of serum, with subsequent analysis of cholesterol in the separated portions. 2. It is shown that both methods of separation yield separated fractions containing substantially the same amounts of cholesterol. 3. Detailed data are given on the errors of measurement for total cholesterol and for cholesterol in the separated lipoprotein fractions. 4. Studies are reported on the stability of cholesterol in stored serum and on paper electrophoresis strips. It is shown that simple drying on filter paper causes no change in cholesterol content and yields a product that is stable for many weeks at ordinary room temperature. 5. The sources of variability in human serum cholesterol values are examined and it is shown that spontaneous intraindividual variability is a much greater source of error than the errors of measurement with these methods.


Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 180
Author(s):  
Kouki Shimizu ◽  
Issei Seiki ◽  
Yoshiyuki Goto ◽  
Takeshi Murata

The intestinal pH can greatly influence the stability and absorption of oral drugs. Therefore, knowledge of intestinal pH is necessary to understand the conditions for drug delivery. This has previously been measured in humans and rats. However, information on intestinal pH in mice is insufficient despite these animals being used often in preclinical testing. In this study, 72 female ICR mice housed in SPF (specific pathogen-free) conditions were separated into nine groups to determine the intestinal pH under conditions that might cause pH fluctuations, including high-protein diet, ageing, proton pump inhibitor (PPI) treatment, several antibiotic treatment regimens and germ-free mice. pH was measured in samples collected from the ileum, cecum and colon, and compared to control animals. An electrode, 3 mm in diameter, enabled accurate pH measurements with a small amount of gastrointestinal content. Consequently, the pH values in the cecum and colon were increased by high-protein diet, and the pH in the ileum was decreased by PPI. Drastic alkalization was induced by antibiotics, especially in the cecum and colon. The alkalized pH values in germ-free mice suggested that the reduction in the intestinal bacteria caused by antibiotics led to alkalization. Alkalization of the intestinal pH caused by antibiotic treatment was verified in mice. We need further investigations in clinical settings to check whether the same phenomena occur in patients.


2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Ramanshu P. Singh ◽  
Shakti Yadav ◽  
Giridhar Mishra ◽  
Devraj Singh

Abstract The elastic and ultrasonic properties have been evaluated at room temperature between the pressure 0.6 and 10.4 GPa for hexagonal closed packed (hcp) hafnium (Hf) metal. The Lennard-Jones potential model has been used to compute the second and third order elastic constants for Hf. The elastic constants have been utilized to calculate the mechanical constants such as Young’s modulus, bulk modulus, shear modulus, Poisson’s ratio, and Zener anisotropy factor for finding the stability and durability of hcp hafnium metal within the chosen pressure range. The second order elastic constants were also used to compute the ultrasonic velocities along unique axis at different angles for the given pressure range. Further thermophysical properties such as specific heat per unit volume and energy density have been estimated at different pressures. Additionally, ultrasonic Grüneisen parameters and acoustic coupling constants have been found out at room temperature. Finally, the ultrasonic attenuation due to phonon–phonon interaction and thermoelastic mechanisms has been investigated for the chosen hafnium metal. The obtained results have been discussed in correlation with available findings for similar types of hcp metals.


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