Advertisement

Topics

Development and validation of a green method for dissolution monitoring of pharmaceutical combinations. Meloxican and pridinol.

08:00 EDT 18th March 2019 | BioPortfolio

Summary of "Development and validation of a green method for dissolution monitoring of pharmaceutical combinations. Meloxican and pridinol."

The development of a chemometric method for monitoring the pharmaceutical dissolution, under green analytical chemistry principles, was reported. Meloxicam (MEL) and pridinol (PRI) were employed as a combination model. Multivariate curve resolution with alternating least squares (MCR-ALS) was proposed to resolve UV spectra of the analytes during pharmaceutical dissolution. Empowering UV-vis spectrophotometry, which is considered an economical, ecological and fast technique, but poor in terms of selectivity. The developed method was validated in accordance to ICH guidelines, fulfilling acceptance criteria for linearity (r > 0.99 in the ranges 3.5-19.6 mg L and 0.81-5.41 mg L for MEL and PRI, respectively), accuracy (96.3% and 100.6% recoveries for MEL and PRI respectively), and precision (RSD < 10%) were evaluated using an independent validation set. Using a commercial sample, the method's accuracy was evaluated against HPLC analysis. Dissolution profiles were obtained using both methods. A point-to-point comparison with Moore and Flanner's factors (f and f) were calculated. Specificity was evaluated by spectral correlation (R>0.950). Additionally, the developed method works on-line and forgoes organic solvents and dilutions, lending itself to automation.

Affiliation

Journal Details

This article was published in the following journal.

Name: Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Pages: 228-233

Links

DeepDyve research library

PubMed Articles [23876 Associated PubMed Articles listed on BioPortfolio]

Development and validation of a discriminatory dissolution method for rifaximin products.

The commercial product of rifaximin (RFX) contains α form. The α form can change to β form on exposure to high humidity that can occur during manufacturing, stability and/or in-use period. It is cr...

Development and Validation of Multiple Reaction Monitoring (MRM) Assays for Clinical Applications.

Selected/multiple reaction monitoring-mass spectrometry (SRM/MRM) is an analytical method that is frequently combined to the use of stable isotope-labeled standard (SIS) peptides for absolute protein ...

Dissolution testing of oral film preparations: experimental comparison of compendial and non-compendial methods.

In vitro dissolution testing is one of the most frequently used tests in pharmaceutical quality control, since evaluation of the drug release profile and estimation of the dosage form performance is e...

Dissolution or Disintegration - Substitution of Dissolution by Disintegration Testing for a Fixed Dose Combination Product.

According to ICH guideline Q6A, dissolution testing can be replaced by disintegration testing if it can be shown that the active pharmaceutical ingredient (API) is highly soluble and the formulation i...

Development and validation of a fast U-HPLC-fluorescent method for the quantification of hydroxychloroquine and its metabolites in patients with lupus.

Hydroxychloroquine (HCQ) is approved for the treatment of systemic lupus erythematosus (SLE). Therapeutic drug monitoring (TDM) of HCQ is necessary to detect non-adherence and to improve treatment eff...

Clinical Trials [8501 Associated Clinical Trials listed on BioPortfolio]

Shockwave Lithotripsy (SWL) Versus Oral Dissolution Therapy (ODT) Versus Combined SWL And ODT For Radiolucent Renal Stone

compare the efficacy of of ultrasound guided SWL versus dissolution therapy versus combined SWL and dissolution therapy in management of 1 - 2.5 cm renal stones.

Lycopene or Green Tea in Treating Patients With Prostate Cancer Previously Enrolled on RADCLIFFE-PROTECT and Currently Enrolled on CRUK-ProMPT

RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or g...

Development and Impact of Multivariate Model-based Strategy to Target High-risk Patients of Postoperative Complication

The objective is therefore to create a risk score for ADEs in an orthopedic and traumatological surgery department. The study is an prospective, observational, cohort trial. A first step ...

Evaluation of Use of Brain Activity Monitoring for Evaluation of Depression Treatment Efficacy

This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.

Green Tea Extract (Polyphenon E) in Preventing Cancer in Healthy Participants

RATIONALE: Green tea extract (Polyphenon E) contains ingredients that may prevent the development of cancer. PURPOSE: This phase I trial is studying how well green tea extract works in pr...

Medical and Biotech [MESH] Definitions

Method of tissue preparation in which the tissue specimen is frozen and then dehydrated at low temperature in a high vacuum. This method is also used for dehydrating pharmaceutical and food products.

Economic aspects of the fields of pharmacy and pharmacology as they apply to the development and study of medical economics in rational drug therapy and the impact of pharmaceuticals on the cost of medical care. Pharmaceutical economics also includes the economic considerations of the pharmaceutical care delivery system and in drug prescribing, particularly of cost-benefit values. (From J Res Pharm Econ 1989;1(1); PharmacoEcon 1992;1(1))

Physiologic or biochemical monitoring of the fetus. It is usually done during LABOR, OBSTETRIC and may be performed in conjunction with the monitoring of uterine activity. It may also be performed prenatally as when the mother is undergoing surgery.

Algae of the division Chlorophyta, in which the green pigment of CHLOROPHYLL is not masked by other pigments. Green algae have over 7000 species and live in a variety of primarily aquatic habitats. Only about ten percent are marine species, most live in freshwater. They are more closely related to the green vascular land PLANTS than any other group of algae.

Method for assessing flow through a system by injection of a known quantity of dye into the system and monitoring its concentration over time at a specific point in the system. (From Dorland, 28th ed)

Advertisement
Quick Search
Advertisement
Advertisement

 


DeepDyve research library

Searches Linking to this Article