scholarly journals Stability-Indicating Analytical Approach for Stability Evaluation of Lactoferrin

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1065
Author(s):  
Nika Osel ◽  
Timeja Planinšek Parfant ◽  
Albin Kristl ◽  
Robert Roškar
Keyword(s):  
Analytical Approach ◽  
Degradation Products ◽  
Reversed Phase ◽  
Size Exclusion ◽  
Spectroscopic Techniques ◽  
Stability Evaluation ◽  
Stability Indicating ◽  
Exclusion Chromatography ◽  
Quality Of Products ◽  
The Stability

Lactoferrin is a multifunctional iron-binding glycoprotein in milk. Due to its potential for the treatment of various diseases, interest in products containing lactoferrin is increasing. However, as a protein, it is prone to degradation, which critically affects the quality of products. Therefore, the main purpose of our work was to develop a stability-indicating analytical approach for stability evaluation of lactoferrin. We were focused on two complementary methods: reversed-phase and size-exclusion chromatography. The stability-indicating nature of the selected methods was confirmed. They were successfully validated by following the ICH guidelines and applied to preliminary lactoferrin stability studies. Up to three degradation products, as well as aggregates and fragments of lactoferrin, were detected in various samples using complementary reversed-phase and size-exclusion chromatographic methods. The analytical approach was additionally extended with three spectroscopic techniques (absorbance, intrinsic fluorescence, and bicinchoninic acid method), which may provide valuable complementary information in some cases. The presented analytical approach allows the stability evaluation of lactoferrin in various samples, including the ability to detect differences in its degradation mechanisms. Furthermore, it has the potential to be used for the quality control of products containing lactoferrin.

scholarly journals Development and Validation of a Novel Stability-Indicating Reversed-Phase Ion-Pair Chromatographic Method for the Quantitation of Impurities in Marbofloxacin Tablets

2018 ◽  
Vol 101 (4) ◽  
pp. 1021-1029
Author(s):  
Priyanka Maheshwari ◽  
Neelima Shukla ◽  
Manish Kumar Dare
Keyword(s):  
Mobile Phase ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Reversed Phase ◽  
Ion Pair ◽  
Stress Conditions ◽  
Main Peak ◽  
Stability Indicating ◽  
Photolytic Degradation ◽  
The Stability

Abstract A stability-indicating isocratic reversed-phase ion-pair chromatographic method was designed for the separation of impurities in the presence of degradation products. Marbofloxacin tablets and a placebo were exposed to the stress conditions of oxidative, acid, base, humidity, thermal, and photolytic degradation. Significant and moderate degradation was observed in acidic and oxidative stress conditions, respectively. The degradation products were well resolved from the main peak and its impurities, thus proving the stability-indicating analytical method. The method was developed by using an XTerra RP18 3.5 μm (150 × 4.6 mm) column, with the mobile phase containing a mixture of buffer (pH 2.5)–methanol–glacial acetic acid (77 + 23 + 0.5, v/v). The flow rate of the mobile phase was 1.2 mL/min, with a column oven temperature of 40°C and a detection wavelength of 315 nm. The proposed method met Veterinary International Conference on Harmonization requirements and was successfully used for impurity quantitation in marbofloxacin tablets.

scholarly journals Studies on Paliperidone in OROS Tablets: Extraction Procedure and Chromatographic Analysis

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Fábio Barbosa ◽  
Luciano Mantovani ◽  
Cássia V. Garcia ◽  
Andreas S. L. Mendez
Keyword(s):  
Oral Delivery ◽  
Degradation Products ◽  
Extraction Procedure ◽  
Reversed Phase ◽  
Forced Degradation ◽  
Phase System ◽  
Stability Indicating ◽  
Ultrasonic Bath ◽  
The Stability ◽  
Liquid Chromatographic

A stability-indicating liquid chromatographic (LC) method was studied for the determination of paliperidone in osmotic-controlled release oral delivery system (OROS) tablets. A tablet extraction procedure was developed by testing the efficiency of solvents (water, HCl, NaOH, acetonitrile, methanol) and techniques (ultrasonic bath, magnetic stirrer), and evaluating the release of the drug with respect to time. A forced degradation study was conducted to demonstrate the stability-indicating power of the method. Chromatographic separation was achieved using an isocratic elution in a reversed-phase system with a mobile phase prepared from a mixture of phosphate buffer and acetonitrile. The use of an ultrasonic bath demonstrated paliperidone release from OROS tablets in a total time of 60 min. Verifying the efficiency of the chromatographic procedure, the theoretical plates (N=12634.21) and tailing factor (tf=1.31) were constant during repeated injections. The retention time of paliperidone was 4.8 min, and the method was validated within the concentration range of 10–50 μg mL-1 (r=0.9999). Adequate reproducibility (RSD% = 0.30–0.59), interday precision (RSD%=1.81), and accuracy were obtained. The proposed method was successfully applied to paliperidone determination in the presence of degradation products, and an efficient extraction procedure from the OROS tablets was developed.

scholarly journals STABILITY EVALUATION OF CAFFEINE-8-THIOGLICOLIC ACID AMIDES, WITH DETERMINED ANTIHYPOXIC EFFECTS

2017 ◽  
Vol 5 ◽  
pp. 1266-1274
Author(s):  
Javor Mitkov ◽  
Maya Georgieva ◽  
Alexander Zlatkov
Keyword(s):  
High Performance ◽  
Thioglycolic Acid ◽  
Degradation Products ◽  
New Product ◽  
Reversed Phase ◽  
Controlled Synthesis ◽  
Stability Evaluation ◽  
Chromatography Method ◽  
Liquid Chromatography Method ◽  
Over Time

This study evaluates a series of caffeine-8-thioglycolic acid amides that were synthesized in the study, for signs of possible degradation. The chemical stability of the test compounds was examined under different conditions of pH and temperature over time. A modified reversed phase-high-performance liquid chromatography method was applied to determine stability and identify possible degradation products. The study identified a new product from oxidative destruction of the test compound through controlled synthesis.

Stability-Indicating Liquid Chromatographic Procedure for Determination of Allantoin in Cosmetic Lotion

1988 ◽  
Vol 71 (2) ◽  
pp. 290-294
Author(s):  
Ramesh J Trivedi
Keyword(s):  
Degradation Products ◽  
Glyoxylic Acid ◽  
Uv Detector ◽  
Stability Indicating ◽  
Assay Procedure ◽  
Relative Standard ◽  
The Stability ◽  
Chromatographic Parameters ◽  
Liquid Chromatographic

Abstract A sensitive, specific liquid chromatographic (LC) procedure was developed for determination of allantoin [(2,5-dioxo-4--imidaazolidinyl) urea or 5-ureidohydantion] in cosmetic lotion. A reverse-phase, ionsuppression mechanism separated allantoin from interfering constituents of the sample matrix, and the compound was determined with a UV detector at 240 nm with a sensitivity limit of ((.20 mg/mL. The chromatographic parameters were optimized for retention time, efficiency, and relative response to the analyte. The assay procedure was validated with spiked laboratory-prepared samples at 100 ± 15% levels. An average recovery of 99.4% with a relative standard deviation of 1.5% (n = 7) was obtained. The stability-indicating characteristics of the method were established by recovery study (99.8%) of samples spiked with known degradation products (urea, allantoic acid, and glyoxylic acid).

scholarly journals Content/Potency Assessment of Botulinum Neurotoxin Type-A by Validated Liquid Chromatography Methods and Bioassays

Toxins ◽  
2019 ◽  
Vol 11 (1) ◽  
pp. 35 ◽  
Author(s):  
Bruna Xavier ◽  
Rafaela Perobelli ◽  
Maurício Walter ◽  
Francielle da Silva ◽  
Sérgio Dalmora
Keyword(s):  
Botulinum Neurotoxin ◽  
Type A ◽  
Reversed Phase ◽  
Size Exclusion ◽  
Mouse Bioassay ◽  
Forced Degradation ◽  
Mean Values ◽  
Botulinum Neurotoxin Type A ◽  
Exclusion Chromatography ◽  
Cell Culture Assay

Botulinum neurotoxin type-A (BoNTA) is one of the seven different serotypes (A to G) produced by Clostridium botulinum. A stability-indicating size-exclusion chromatography (SEC) method was developed and validated, and the specificity was confirmed by forced degradation study, interference of the excipients, and peaks purity. The method was applied to assess the content and high-molecular-weight (HMW) forms of BoNTA in biopharmaceutical products, and the results were compared with those of the LD50 mouse bioassay, the T−47D cell culture assay, and the reversed-phase chromatography (RPC) method, giving mean values of 0.71% higher, 0.36% lower, and 0.87% higher, respectively. Aggregated forms showed significant effects on cytotoxicity, as well as a decrease in the bioactivity (p < 0.05). The employment of the proposed method in conjunction with the optimized analytical technologies for the analysis of the intact and altered forms of the biotechnology-derived medicines, in the correlation studies, enabled the demonstration of the capability of each one of the methods and allowed for great improvements, thereby assuring their safe and effective use.

Stability-indicating LC method for the determination of cephalothin in lyophilized powder for injection

2014 ◽  
Vol 6 (12) ◽  
pp. 4437-4445 ◽  
Author(s):  
Karen de Souza Rugani ◽  
Hérida Regina Nunes Salgado
Keyword(s):  
Liquid Chromatography ◽  
Degradation Products ◽  
Reversed Phase ◽  
Forced Degradation ◽  
Antimicrobial Compound ◽  
Reversed Phase Liquid Chromatography ◽  
Stability Indicating ◽  
Forced Degradation Studies ◽  
Phase Liquid

A stability-indicating gradient reversed phase liquid chromatography (RP-LC) method has been developed for the quantitative determination of cephalothin (CET), an antimicrobial compound, in the presence of its impurities and degradation products generated from forced degradation studies.

Separation of Liquiritin by Two-Dimensional Liquid Chromatography

2012 ◽  
Vol 455-456 ◽  
pp. 1232-1238 ◽  
Author(s):  
Jing Xiang Cong ◽  
Shao Yan Wang ◽  
Hong Gao
Keyword(s):  
Liquid Chromatography ◽  
Reversed Phase ◽  
Normal Phase ◽  
Size Exclusion ◽  
Two Dimensional ◽  
Target Compound ◽  
Reversed Phase Chromatography ◽  
Complex Samples ◽  
Exclusion Chromatography ◽  
Licorice Extract

Two-dimensional liquid chromatography (2DLC) is an important technology for the separation and analysis of complex samples. Liquiritin, an important active component in licorice, was chosen as the target compound and it was separated by three kinds of off-line 2DLC, i.e. size exclusion chromatography × reversed phase chromatography, normal phase × reversed phase chromatography and reversed phase chromatography × reversed phase chromatography (SEC×RP, NP×RP and RP×RP). The chromatographic conditions were selected and the 2D systems were combined. The results show that it is feasible to separate Liquiritin from licorice extract using 2DLC. Among the 2D modes mentioned above, the highest purity of Liquiritin was obtained in the RP×RP mode, and the concentration of Liquiritin was increased most significantly in the NP×RP mode.

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