Stability Indicating TLC Method for Quantification of Brexpiprazole in Bulk and Its Pharmaceutical Dosage Form and Determination of Content Uniformity.

08:00 EDT 16th May 2019 | BioPortfolio

Summary of "Stability Indicating TLC Method for Quantification of Brexpiprazole in Bulk and Its Pharmaceutical Dosage Form and Determination of Content Uniformity."

A sensitive, selective and precise high performance thin layer chromatographic method has been developed and validated for the quantification of Brexpiprazole in bulk drug and in pharmaceutical dosage form. The method employed HPTLC aluminum plates (pre-coated with silica gel 60 F254) as stationary phase while n-butanol was used as mobile phase. The Rf value of Brexpiprazole was observed to be 0.38. The densitometric analysis was carried out in absorbance mode at 215 nm. The linear regression analysis data for the calibration plots showed a good linear relationship for Brexpiprazole over a concentration range of 200-1,600 ng band-1. The limit of detection and limit of quantification for Brexpiprazole was found to be 66 and 200 ng band-1. To find out the possible degradation pathway, forced degradation studies were performed. The stock solutions of Brexpiprazole (1,000 μg mL-1) were subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo degradation. The drug was found to be susceptible to acid and alkali hydrolysis, chemical oxidation, photo degradation and dry heat. The degraded product peaks were well resolved from the pure drug peak with significant difference in their Rf values. Stressed samples were analyzed using developed HPTLC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of Brexpiprazole in marketed formulation and determination of content uniformity of tablet formulation. Statistical analysis showed that the method is repeatable, selective, and precise.


Journal Details

This article was published in the following journal.

Name: Journal of chromatographic science
ISSN: 1945-239X


DeepDyve research library

PubMed Articles [18379 Associated PubMed Articles listed on BioPortfolio]

Development and Validation of Stability Indicating UPLC-PDA/MS for the Determination of Imiquimod and its Eight Related Substances: Application to Topical Cream.

A stability indicating analytical method for imiquimod and its related impurities was developed by ultra-pressure liquid chromatography (UPLC) using design of experiments. This method could quantify i...

Stability indicating spectrophotometric methods for quantitative determination of carbamazepine and its degradation product, iminostilbene, in pure form and pharmaceutical formulations.

A stressed study on the stability and degradation behavior under ICH forced degradation conditions of most widely used antiepileptic drug; carbamazepine (CMZ) is presented in this work. The research a...

A simple innovative spectrofluorometric method for the determination of alendronate in bulk and in pharmaceutical tablets.

Sodium alendronate is the first in a pharmacological class known as bisphosphonates, used for treatment of various bone diseases. Assay of bisphosphonates by a spectroscopic technique is very challeng...

In Silico, In vitro and In vivo Metabolite Identification of Brexpiprazole using Ultra High Performance Liquid Chromatography-Quadrupole Time-of-Flight Mass Spectrometry.

Brexpiprazole is a novel serotonin-dopamine activity modulator approved by USFDA in July 2015 for the treatment of schizophrenia and as an adjunctive therapy with other antidepressants for major depre...

Analytical aspects of printed oral dosage forms.

Printing technologies, both 2D and 3D, have gained considerable interest during the last years for manufacturing of personalized dosage forms, tailored to each patient. Here we review the research wor...

Clinical Trials [4655 Associated Clinical Trials listed on BioPortfolio]

Bioequivalence Study of Brexpiprazole Orally Disintegrating Tablets (ODT) 2mg

To investigate the bioequivalence of brexpiprazole ODT 2 mg and brexpiprazole conventional tablet 2 mg

Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia

This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of A...

Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-bli...

Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who requ...

Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia

To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered subcutaneously or intramuscularly in adults with schizophrenia.

Medical and Biotech [MESH] Definitions

Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form.

Substances which are of little or no therapeutic value, but are necessary in the manufacture, compounding, storage, etc., of pharmaceutical preparations or drug dosage forms. They include SOLVENTS, diluting agents, and suspending agents, and emulsifying agents. Also, ANTIOXIDANTS; PRESERVATIVES, PHARMACEUTICAL; COLORING AGENTS; FLAVORING AGENTS; VEHICLES; EXCIPIENTS; OINTMENT BASES.

The chemical and physical integrity of a pharmaceutical product.

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.

Completed forms of the pharmaceutical preparation in which prescribed doses of medication are included. They are designed to resist action by gastric fluids, prevent vomiting and nausea, reduce or alleviate the undesirable taste and smells associated with oral administration, achieve a high concentration of drug at target site, or produce a delayed or long-acting drug effect. They include CAPSULES; LINIMENTS; OINTMENTS; PHARMACEUTICAL SOLUTIONS; POWDERS; TABLETS; etc.

Quick Search


DeepDyve research library

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Searches Linking to this Article