Monitoring a potential carcinogen in pharmaceutical formulations at the low part per billion level

1987 ◽  
Vol 386 ◽  
pp. 57-63 ◽  
Author(s):  
Gregory Severin
Keyword(s):  
Pharmaceutical Formulations ◽  
Potential Carcinogen

Development of Validated Stability Indicating HPTLC Method for Assay of Ozagrel and its Pharmaceutical Formulations

2018 ◽  
pp. 36-48 ◽  
Author(s):  
Vishal N Kushare ◽  
Sachin S Kushare
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
Pharmaceutical Formulations ◽  
Base Hydrolysis ◽  
Assay Method ◽  
Related Substance ◽  
Stability Indicating ◽  
Regular Production ◽  
Hptlc Method

The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for Ozagrel in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: triethylamine (6.5: 4.0: 0.1 v/v/v). The system was found to give compact spot for Ozagrel (Rf value of 0.40 ± 0.010). Densitometric analysis of Ozagrel was carried out in the absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.999 with respect to peak area in the concentration range 30 - 120 ng/spot. The developed HPTLC method was validated with respect to accuracy, precision, recovery and robustness. Also to determine related substance and assay determination of Ozagrel that can be used to evaluate the quality of regular production samples. The developed method can also be conveniently used for the assay determination of Ozagrel in pharmaceutical formulations. The limits of detection and quantitation were 4.069 and 12.332 ng/spot, respectively by height. Ozagrel was subjected to acid and alkali hydrolysis, oxidation, photochemical and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and heat conditions. This indicates that the drug is susceptible to acid, base hydrolysis, oxidation and heat. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of Ozagrel in bulk drug and tablet formulation.

Novel UV Spectrophotometric Method for the Quantitative Analysis of CefpodoximeProxetil in Pharmaceutical Formulations by First Derivative Technique

2017 ◽  
Vol 8 (03) ◽  
Author(s):  
Potdar S. S. ◽  
Karajgi S. R. ◽  
Simpi C. C. ◽  
Kalyane N. V.
Keyword(s):  
Quantitative Analysis ◽  
Spectrophotometric Method ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
First Derivative ◽  
Good Linearity ◽  
Beer's Law ◽  
Beer’S Law ◽  
Tablet Dosage ◽  
Ich Guideline

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.

Colorimetric Determination of Amoxicillin in Pure and some Pharmaceutical Formulations Via Reaction with Potassium Permanganate as Oxidant Reagent

2019 ◽  
Vol 10 (02) ◽  
Author(s):  
Abbas Shebeeb Al-kadumi ◽  
Sahar Rihan Fadhel ◽  
Mohammed Abdullah Ahmed ◽  
Luma Amer Musa
Keyword(s):  
Potassium Permanganate ◽  
Pharmaceutical Preparations ◽  
Pharmaceutical Formulations ◽  
Atomic Emission ◽  
Basic Medium ◽  
Photometric Method ◽  
Colorimetric Determination ◽  
Spectrophotometric Methods ◽  
Label Claim

We proposed two simple, rapid, and convenient spectrophotometric methods are described for the determination of Amoxicillin in bulk and its pharmaceutical preparations. They are based on the measurement of the flame atomic emission of potassium ion (in first method) and colorimetric determination of the green colored solution for manganite ion at 610 nm formed after reaction of Amoxicillin with potassium permanganate as oxidant agent (in the second method) in basic medium. The working conditions of the methods were investigated and optimized. Beer's law plot showed a good correlation in the concentration range of 5-45 μg/ml. The detection limits and relative standared deviations were (2.573, 2.814 μg/ml) (2.137, 2.498) for the flame emission photometric method and (1.844, 2.016 μg/ml) (1.645,1.932) for colorimetric methods for capsules and suspensions respectively. The methods were successfully applied to the determination of Amoxicillin in capsules and suspensions, and the obtained results were in good agreement with the label claim. No interference was observed from the commonly encountered additives and expectancies.

Pharmaceutical Polymers - A Review

2019 ◽  
Vol 9 (01) ◽  
pp. 27-33
Author(s):  
Naveen Kumar ◽  
Sonia Pahuja ◽  
Ranjit Sharma
Keyword(s):  
Drug Release ◽  
Industrial Revolution ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Products ◽  
Water Soluble ◽  
Taste Masking ◽  
Natural Polymers ◽  
Pharmaceutical Dosage Forms ◽  
Pharmaceutical Applications ◽  
Pharmaceutical Industries

Humans have taken advantage of the adaptability of polymers for centuries in the form of resins, gums tars, and oils. However, it was not until the industrial revolution that the modern polymer industry began to develop. Polymers represent an important constituent of pharmaceutical dosage forms. Polymers have played vital roles in the formulation of pharmaceutical products. Polymers have been used as a major tool to manage the drug release rate from the formulations. Synthetic and natural-based polymers have found their way into the biomedical and pharmaceutical industries. Synthetic and Natural polymers can be produced with a broad range of strength, heat resistance, density, stiffness and even price. By constant research into the science and applications of polymers, they are playing an ever-increasing role in society. Diverse applications of polymers in the present pharmaceutical field are for controlled drug release. Based on solubility pharmaceutical polymers can be classified as water-soluble and water-insoluble. In general, the desirable polymer properties in pharmaceutical applications are film forming, adhesion, gelling, thickening, pH-dependent solubility and taste masking. General pharmaceutical applications of polymers in various pharmaceutical formulations are also discussed

The Impact of Bioconjugation on the Interfacial Activity of a Protein Biosurfactant

2018 ◽  
Author(s):  
Hossam H Tayeb ◽  
Marina Stienecker ◽  
Anton Middelberg ◽  
Frank Sainsbury
Keyword(s):  
Polyethylene Glycol ◽  
Colloidal Stability ◽  
Point Mutations ◽  
Pharmaceutical Formulations ◽  
Industrial Processes ◽  
Parent Molecule ◽  
Site Specific ◽  
Interfacial Activity ◽  
Surface Active ◽  
The Impact

Biosurfactants, are surface active molecules that can be produced by renewable, industrially scalable biologic processes. DAMP4, a designer biosurfactant, enables the modification of interfaces via genetic or chemical fusion to functional moieties. However, bioconjugation of addressable amines introduces heterogeneity that limits the precision of functionalization as well as the resolution of interfacial characterization. Here we designed DAMP4 variants with cysteine point mutations to allow for site-specific bioconjugation. The DAMP4 variants were shown to retain the structural stability and interfacial activity characteristic of the parent molecule, while permitting efficient and specific conjugation of polyethylene glycol (PEG). PEGylation results in a considerable reduction on the interfacial activity of both single and double mutants. Comparison of conjugates with one or two conjugation sites shows that both the number of conjugates as well as the mass of conjugated material impacts the interfacial activity of DAMP4. As a result, the ability of DAMP4 variants with multiple PEG conjugates to impart colloidal stability on peptide-stabilized emulsions is reduced. We suggest that this is due to constraints on the structure of amphiphilic helices at the interface. Specific and efficient bioconjugation permits the exploration and investigation of the interfacial properties of designer protein biosurfactants with molecular precision. Our findings should therefore inform the design and modification of biosurfactants for their increasing use in industrial processes, and nutritional 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.  

Multivariate Statistical Analysis Regarding the Formulation of Oxicam-Based Pharmaceutical Hydrogels

2017 ◽  
Vol 68 (4) ◽  
pp. 726-731
Author(s):  
Lenuta Maria Suta ◽  
Anca Tudor ◽  
Colette Roxana Sandulovici ◽  
Lavinia Stelea ◽  
Daniel Hadaruga ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Multivariate Statistical Analysis ◽  
Pharmaceutical Formulations ◽  
Analysis Data ◽  
Multivariate Statistical ◽  
Predictive Variables ◽  
Rapid Release ◽  
Computational Data ◽  
Experimental Protocols ◽  
Formulation Factors

In this paper, it was analysed the influence of formulation factors over obtaining oxicam hydrogels, using the statistical analysis. Data analysis and predictive modeling by multivariate regression offers a large number of possible explanatory/predictive variables. Therefore, variable selection and dimension reduction is a major task for multivariate statistical analysis, especially for multivariate regressions. The statistical analysis and computational data processing of responses obtained from different pharmaceutical formulations, via different experimental protocols, lead to the optimization of the formulation process. It was found that the most suitable pharmaceutical formulations based on oxicams with the possibility of rapid release contained cyclodextrin, in particular 2-hydroxypropyl-b-cyclodextrin.

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