scholarly journals Stability of Tilo® tablets formulation obtained from dry extract of Justice pectoralis Jacq.

2015 ◽  
Vol 51 (1) ◽  
pp. 193-202
Author(s):  
Jorge E. Rodríguez-Chanfrau ◽  
Yanier Núñez-Figueredo ◽  
Viviana Fuste-Moreno

Justicia pectoralis Jacq., Acanthaceae, is a herb known popularly in Cuba as Tilo and used traditionally as sedative. The development in a solid pharmaceutical (Tablets 100 mg) using dry extract of Justicia pectolaris aqueous extract is of interest for the development of phytomedicines, which uses this active raw material. The aim of the present study was to carry out chemical and biological stability studies to the formulation. A method of coumarin determination by High Performance Liquid Chromatography (HPLC) was used and validated. The stability studies during different periods of time (24 months) showed a stability of the product stored at 32 ± 2 °C, and protected of the light.

2019 ◽  
Vol 16 ◽  
Author(s):  
Joanna Wittckind Manoel ◽  
Camila Ferrazza Alves Giordani ◽  
Livia Maronesi Bueno ◽  
Sarah Chagas Campanharo ◽  
Elfrides Eva Sherman Schapoval ◽  
...  

Introduction: Impurity analysis is an important step in the quality control of pharmaceutical ingredients and final product. Impurities can arise from drug synthesis or excipients and even at small concentrations may affect product efficacy and safety. In this work two methods using high performance liquid chromatography (HPLC) were developed and validated for the evaluation of besifloxacin and its impurity synthesis, with isocratic elution and another with gradient elution. Method: The analysis by HPLC in isocratic elution mode was performed using a cyano column maintained at 25 °C. The mobile phase was composed by 0.5% triethylamine (pH 3.0): acetonitrile (88:12 v/v) eluted at a flow rate of 1.0 ml/min with detection at 330 nm. The gradient elution method was carried out with the same column and mobile phase components only modifying the rate between organic and aqueous phase during analysis. The procedures have been validated according to internationally accepted guidelines, observing results within acceptable limits. Results: The methods presented were found to be linear in the 140 to 260 µg/ml range for besifloxacin and 0.3 to 2.3 µg/ml for an impurity named A. The limits of detection and quantification were respectively 0.07 and 0.3 µg/ml for impurity A, with a 20 µL injection volume. The precision achieved for all analyses performed provided RSD inter-day equal to 6.47 and 6.36% for impurity A with isocratic elution and gradient, respectively. The accuracy was higher than 99% and robustness exhibited satisfactory results. In the isocratic method an analysis time of 25 min and 15 min was obtained for gradient. For impurity A, the number of theoretical plates in the isocratic mode was about 5000 while in the gradient mode it was about 45000, hence, it made the column more efficient by changing the mobile phase composition during elution. In besifloxacin raw material and in pharmaceutical product used in this study, other related impurities were present but but impurity A was searched for and not detected Conclusion: The proposed methods can be applied for quantitative determination of impurities in the analysis of the besifloxacin raw material, as well as in ophthalmic suspension of the drug, considering the quantitation limit.


1992 ◽  
Vol 262 (2) ◽  
pp. G351-G358
Author(s):  
R. Zhang ◽  
S. Barnes ◽  
R. B. Diasio

Mechanisms responsible for the difference in the relative amounts of taurine- and glycine-conjugated bile acid N-acyl amidates (Tau/Gly ratio) are not fully understood. In the present study, the stability of taurine- and glycine-conjugated bile acid N-acyl amidates during intestinal transit and absorption was examined to investigate the contribution of intestinal deconjugation to the Tau/Gly ratio in rat bile. Radiolabeled chenodeoxycholic acid (CDC) and its N-acyl amidates with glycine (CDC-Gly) or taurine (CDC-Tau) were introduced into the lumen of the upper small intestine in the biliary fistula rats, and radioactive metabolites in bile, blood, urine, and tissues were identified and quantitated by high-performance liquid chromatography. Results indicated that 1) extensive deconjugation of CDC-Gly occurs during intestinal absorption; 2) CDC-Tau is recovered in bile largely intact; and 3) newly synthesized CDC-Tau and CDC-Gly are formed in a ratio of less than 2:1 after administration of [14C]-CDC. In summary, the present study demonstrates that resistance of taurine-conjugated bile acid N-acyl amidates to hydrolysis in the intestine, rather than a difference in synthesis of taurine- and glycine-conjugated N-acyl amidates in liver, may account for the high Tau/Gly ratio in rat bile.


2019 ◽  
Vol 18 (2) ◽  
pp. 73-77
Author(s):  
L. M. Fedoseeva ◽  
Yu. I. Chistova

The purpose of this work is to study of phenolic compounds in the dry extract of dandelion herb and large burdock leaf tea.Materials and methods . The separation and identification of phenolic compounds of dry extract of dandelion herb and large burdock leaf tea by thin-layer chromatography and high-performance liquid chromatography with UV-detectionhas been carried out.Results . As a result of research, it has been established that during TLC the optimal system for the separation of phenolic compounds is the ethyl acetate – formic acid – water system (10:2:3). On the chromatogram four spots were found corresponding to the value of Rf and fluorescence in UV-light to flavonoids of the flavone group and phenolic acids (chlorogenic and caffeic acids). For further identification of phenolic compounds using HPLC, eight peaks were found, which in terms of retention time and spectral characteristics correspond to phenologlycosides, chlorogenic acid, caffeic acid derivatives, ferulic acid, umbelliferone.Conclusions . Thus, the dry extract of dandelion herb and large burdock leaf tea contains hydroxycinnamic acids and their derivatives, compounds of coumarin nature, phenologlycosides.


2016 ◽  
Vol 47 (4) ◽  
Author(s):  
Jebur & et al.

This study was aimed to know the efficiency of partially purified L- asparaginase produced from local isolate from Erwinia spp. to reduce the percentage of acrylamide formed in Biscuit. Four types of biscuit from wheat flour were prepared (T1, T2, T3, T4),and T1 as control. High performance liquid chromatography technique was used to estimate acrylamide ratio in biscuit , Effect of enzyme addition  on flour chemical and rheological properties was studied, also dough behavior ,gluten percentage, water absorption and amylase enzyme activity was estimated. The results revealed  that  the  addition of  experimental asparaginase ( specific activity 20.5 unite mg-1 ) with 1% of flour weight lead to reduce in acrylamide formation in Biscuit  to 89 %  compared  to  control sample ( in absence of enzyme ) . Moreover, the addition of Asparagine to flour at 0.1 % of its weight, where L- asparaginase was available caused a negative effect on enzyme efficiency in reducing the acrylamide in biscuit. So the level of acrylamide was reduced to 57.7 %. In the other hand , the percentage of acryl amide in biscuit was increased to   233 % when the asparagine was added to mixture in absence of L- asparaginase .Addition of  the enzyme to flour have no effect on the percentage value of gluten but improved the  stability of dough .The  enzyme  addition also led to increase amylases activities.  Addition of experimental enzyme had no effect on quality and sensory evaluation of biscuit.


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