Investigation of tryptophan-related yellowing in parenteral amino acid solution: Development of a stability-indicating method and assessment of degradation products in pharmaceutical formulations

2020 ◽  
Vol 177 ◽  
pp. 112839 ◽  
Author(s):  
Nina Unger ◽  
Antonio Ferraro ◽  
Ulrike Holzgrabe
Keyword(s):  
Amino Acid ◽  
Acid Solution ◽  
Degradation Products ◽  
Pharmaceutical Formulations ◽  
Amino Acid Solution ◽  
Stability Indicating ◽  
Stability Indicating Method

STABILITY INDICATING RP-HPLC METHOD FOR SEPARATION AND QUANTIFICATION OF RELATED SUBSTANCES OF TICLOPIDINE IN BULK AND PHARMACEUTICAL FORMULATIONS

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (08) ◽  
pp. 75-78
Author(s):  
B. S. Venkateswarlu ◽  
Prudhvi N. Sai ◽  
Keyword(s):  
Degradation Products ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Standard Drug ◽  
Stability Indicating ◽  
Stress Studies ◽  
Related Substances ◽  
Stability Indicating Method ◽  
Stress Degradation ◽  
Bulk Drug

A simple, specific, accurate and stable reverse phase liquid chromatographic method was developed for the simultaneous determination of ticlopidine and its related impurities A and B in bulk drug and tablet dosage forms. The analysis has been performed on XTerra C18 column (250 mm×4.6 mm; 5 µ id) and mobile phase containing of methanol and pH 6.8 phosphate buffer in the ratio of 80:20 (V/V). The detection was carried at 228 nm with a flow rate of 1.0 mL/min. The retention times were found to be 8.9, 5.98 and 4.62 min for ticlopidine, impurities A and B, respectively. The method was validated according to ICH guidelines. The method was validated for specificity, precision, linearity, accuracy and robustness. The linearity range of 50-200 µg/mL for ticlopidine and 0.5-2.0 µg/mL for impurity A and B. The recoveries of ticlopidine and impurities were found to be within the range of 98-102 and the % RSD in each spiked level was found to be less than 2. The stress degradation studies confirmed that the method was effectively separate the degradation products and impurities formed in the stress studies and hence the method was found to be stability indicating method. The method can effectively quantify the standard drug ticlopidine and its impurities A and B in bulk drug and pharmaceutical formulations.

Stability Indicating Liquid Chromatographic Method for the Determination of Fenofibrate and its Application to Kinetic Studies

2013 ◽  
Vol 5 (4) ◽  
pp. 1866-1874
Author(s):  
K. Srinivasa Rao ◽  
Keshar N K ◽  
N Jena ◽  
M.E.B Rao ◽  
A K Patnaik
Keyword(s):  
Degradation Products ◽  
Kinetic Studies ◽  
Pharmaceutical Formulations ◽  
Assay Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Zero Order Kinetics ◽  
Relative Standard ◽  
Liquid Chromatographic

A stability-indicating LC assay method was developed for the quantitative determination of fenofibrate (FFB) in pharmaceutical dosage form in the presence of its degradation products and kinetic determinations were evaluated in acidic, alkaline and peroxide degradation conditions. Chromatographic separation was achieved by use of Zorbax C18 column (250 × 4.0 mm, 5 μm). The mobile phase was established by mixing phosphate buffer (pH adjusted 3 with phosphoric acid) and acetonitrile (30:70 v/v). FFB degraded in acidic, alkaline and hydrogen peroxide conditions, while it was more stable in thermal and photolytic conditions. The described method was linear over a range of 1.0-500 μg/ml for determination of FFB (r= 0.9999). The precision was demonstrated by relative standard deviation (RSD) of intra-day (RSD= 0.56– 0.91) and inter-day studies (RSD= 1.47). The mean recovery was found to be 100.01%. The acid and alkaline degradations of FFB in 1M HCl and 1M NaOH solutions showed an apparent zero-order kinetics with rate constants 0.0736 and 0.0698  min−1 respectively and the peroxide degradation with 5% H2O2 demonstrated an apparent first-order kinetics with rate constant k = 0.0202 per min. The t1/2, t90   values are also determined for all the kinetic studies. The developed method was found to be simple, specific, robust, linear, precise, and accurate for the determination of FFB in pharmaceutical formulations.  

Intravenous Alimentation and Insensible Water Loss in Low-Birth- Weight Infants

PEDIATRICS ◽  
1979 ◽  
Vol 63 (4) ◽  
pp. 543-546
Author(s):  
Keith H. Marks ◽  
Timothy P. Farrell ◽  
Zvi Friedman ◽  
M. Jeffrey Maisels
Keyword(s):  
Amino Acid ◽  
Acid Solution ◽  
Water Loss ◽  
Caloric Intake ◽  
Constant Infusion ◽  
Fat Emulsion ◽  
Low Birth Weight Infants ◽  
Amino Acid Solution ◽  
Intravenous Fat Emulsion ◽  
Multiple Measurements

Insensible water loss (IWL) was measured in six premature infants, betWeen 4 and 21 days of age, by continuous weight monitoring on an electronic balance inside an incubator. Multiple measurements of IWL were made during the sequential infusion of 10% dextrose in 0.225% NaCl, 10% dextrose-amino acid solution, or 10% dextrose-amino acid and a commercial intravenous fat emulsion. Each solution was administered for three hours by constant infusion through a scalp vein needle. The order of the infusion was random and a 30-to 60-minute infusion with 5% dextrose water was given between each solution. During the infusion of 10% dextrose in 0.225% NaCl and 10% dextrose + amino acid solution, IWL was 1.0 ± 0.8 gm/kg/ hr and 1.1 ± 0.8 gm/kg/hr, respectively. In contrast, IWL increased significantly to 1.6 ± 0.7 gni/kg/hr when additional calories were given using the 10% dextrose-amino acid with the intravenous fat emulsion (P < .005). There was a positive correlation between caloric intake and IWL. These data suggest that parenteral nutrition solutions with intravenous fat emulsion are rapidly metabolized and the increase in IWL is probably secondary to an increase in thermogenesis.

Effect of Balanced Amino Acid Solution on Protein Metabolism after Surgery

1990 ◽  
Vol 17 (2) ◽  
pp. 100-103
Author(s):  
J. Figueras ◽  
E. Ramos ◽  
J.M. Llop ◽  
N. San-Juan ◽  
J. Marti
Keyword(s):  
Amino Acid ◽  
Acid Solution ◽  
Protein Metabolism ◽  
Amino Acid Solution

scholarly journals Development of a Stability Indicating Method for Simultaneous Analysis of Five Water-Soluble Vitamins by Liquid Chromatography

2018 ◽  
Vol 3 (4) ◽  
pp. 207-218 ◽  
Author(s):  
Mouloud Yessaad ◽  
Lise Bernard ◽  
Daniel Bourdeaux ◽  
Philip Chennell ◽  
Valérie Sautou
Keyword(s):  
Liquid Chromatography ◽  
Degradation Products ◽  
Pharmaceutical Preparations ◽  
Water Soluble ◽  
Alkaline Solutions ◽  
Array Detector ◽  
Forced Degradation ◽  
Metaphosphoric Acid ◽  
Stability Indicating ◽  
Stability Indicating Method

Abstract Background Water-soluble vitamins are often included simultaneously in pharmaceutical formulations as food complements or in parenteral nutrition mixtures. Given their sensitivity to heat, light or pH variations, it is important to study their stability using validated stability indicating methods. We thus aimed to validate a liquid chromatography (LC) stability-indicating method for the simultaneous quantification of 5 water-soluble vitamins. Methods We analyzed four water-soluble B vitamins (nicotinamide, pyridoxine, folic acid, cyanocobalamin) and ascorbic acid using a LC method with diode array detector. They were separated on a C18 stationary phase under gradient elution of solvent A [0.2 % of metaphosphoric acid in water and acetonitrile 98:2] and solvent B (100 % acetonitrile). All vitamins were subjected to forced degradation conditions and we showed that the obtained degradation products didn’t interfere with the vitamins. Results The method allows the separation of the 5 water-soluble vitamins in a 30 minute run without any interference from the breakdown products obtained with acid/alkaline solutions, hydrogen peroxide, temperature and light. It meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity. Conclusions This stability-indicating method can be used for carrying out stability studies of water-soluble vitamins in pharmaceutical preparations.

Effects of plasma amino acid and hormone levels on renal hemodynamics in humans

1988 ◽  
Vol 255 (3) ◽  
pp. F444-F449 ◽  
Author(s):  
P. Castellino ◽  
C. Giordano ◽  
A. Perna ◽  
R. A. DeFronzo
Keyword(s):  
Growth Hormone ◽  
Amino Acid ◽  
Acid Solution ◽  
Growth Hormone Secretion ◽  
Renal Hemodynamics ◽  
Time Sequence ◽  
Plasma Amino Acid ◽  
Base Line ◽  
Amino Acid Solution ◽  
Hormone Levels

The effect of plasma amino acid and hormone (insulin, glucagon, and growth hormone) levels on renal hemodynamics was studied in 18 healthy subjects. The following four protocols were employed: study 1, a balanced amino acid solution was infused for 3 h to increase plasma amino acid concentrations two to three times base line; study 2, the same amino acid solution was infused with somatostatin (SRIF) and infusions of insulin, glucagon, and growth hormone were concomitantly administered to replace the time sequence of increase in peripheral concentrations of these hormones as observed during study 1; study 3, the same amino acid infusion was administered with SRIF plus infusions of insulin, glucagon, and growth hormone to maintain plasma hormone concentrations constant at the basal level; study 4, SRIF was infused with insulin, glucagon, and growth hormone to reproduce the time sequence of increase of these hormones as observed in study 1; amino acids were not infused in this study. During study 1, glomerular filtration rate (GFR) and renal plasma flow (RPF) rose by 19 and 21%, respectively. During study 2 both the time sequence of and magnitude of rise in GFR and in RPF were similar to the changes observed during study 1. In studies 3 and 4 neither RPF nor GFR changed significantly from base line. These results indicate that 1) hyperaminoacidemia stimulates insulin/glucagon/growth hormone secretion and causes a modest rise in GFR and RPF; and 2) if hyperaminoacidemia is created while maintaining basal hormone levels constant or if plasma insulin/glucagon/growth hormone levels are increased while maintaining the plasma amino acid concentration at basal levels, neither RPF nor GFR rise.(ABSTRACT TRUNCATED AT 250 WORDS)

Therapy of myocardial infarction with metabolic agents

1986 ◽  
Vol 67 (5) ◽  
pp. 325-328
Author(s):  
A. E. Vtorov ◽  
L. A. Leshchinsky ◽  
L. T. Pimenov
Keyword(s):  
Myocardial Infarction ◽  
Amino Acid ◽  
Connective Tissue ◽  
Acid Solution ◽  
Anabolic Steroid ◽  
Amino Acid Solution ◽  
Complex Therapy ◽  
Hospital Rehabilitation ◽  
Tissue Metabolites

The aim of the present work was to study in dynamics the concentration of connective tissue metabolites (free and peptide-bound oxyproline) in patients with myocardial infarction at different stages of in-hospital rehabilitation when using metabolic agents as part of complex therapy: free crystalline amino acid solution - alvesin-nova (GDR) in combination with the anabolic steroid retabolol.

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