Development and validation of a HPLC method for the determination of sertraline and three non-chiral related impurities.

14:05 EST 21st November 2014 | BioPortfolio

Summary of "Development and validation of a HPLC method for the determination of sertraline and three non-chiral related impurities."

In this study, a screening on reversed-phase stationary phases (including C(8), C(18), CN, PEG and amide) was carried out in order to obtain an efficient HPLC method for the determination of sertraline and three of its more closely related synthetical and non-chiral impurities, without using ion-pair reagents. The best results in terms of both retention time and resolution of the target analytes were obtained with a Zorbax Bonus-RP column, which contains a polar amide group embedded in a C(14) alkyl chain. Once the most suitable stationary phase was chosen, the HPLC method was optimized by using a factorial design, evaluating three quantitative factors (column temperature, buffer pH and buffer concentration) in order to find the best conditions which maximize the resolution between impurities A and B (positional isomers) and minimize the total run time. The final HPLC conditions were set by means of a second experimental design, which allowed optimizing the effects of the buffer pH and the proportion of methanol in the mobile phase. The optimal conditions for simultaneously determining sertraline and its impurities, being baseline separated in less than 10 min, were finally obtained with Zorbax Bonus-RP column (150 mmx4.6mm, 5 microm), under isocratic conditions with phosphate buffer (pH 2.8; 10mM)-methanol (63:37, v/v) at 50 degrees C, at the flow-rate of 1.0 mL/min. UV detection was set at 220 nm. This method was successfully validated following ICH guidelines and it proved to be reliable for the determination of sertraline and related impurities in tablets as pharmaceutical forms.

Affiliation

Facultad de Farmacia, Universidad San Pablo-CEU, Urbanización Montepríncipe, Boadilla del Monte, 28668 Madrid, Spain.

Journal Details

This article was published in the following journal.

Name: Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Pages: 122-9

Links

PubMed Articles [20374 Associated PubMed Articles listed on BioPortfolio]

A conventional HPLC-MS method for the simultaneous determination of ofloxacin and cefixime in plasma: Development and validation.

A simple, rapid, and sensitive high performance liquid chromatography-mass spectrometry (HPLC-MS) method was developed and validated for the simultaneous determination of ofloxacin (OFL) and cefixime ...

Validation of assay indicating method development of meloxicam in bulk and some of its tablet dosage forms by RP-HPLC.

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantification of Meloxicam in bulk and tablet dosage form with greater pr...

Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Phenoxyethanol, Methylparaben, Propylparaben, Mometasone Furoate, and Tazarotene in Topical Pharmaceutical Dosage Formulation.

A stability-indicating RP-HPLC method has been developed and validated for the simultaneous determination of phenoxyethanol (PE), methylparaben (MP), propylparaben (PP), mometasone furoate (MF), and t...

Simultaneous HPLC determination of 22 components of essential oils; method robustness with experimental design.

The aim of the present study was the development and validation of a simple, precise and specific reversed phase HPLC method for the simultaneous determination of 22 components present in different es...

Chemometrics-Assisted UV Spectrophotometric and RP-HPLC Methods for the Simultaneous Determination of Tolperisone Hydrochloride and Diclofenac Sodium in their Combined Pharmaceutical Formulation.

Chemometrics-assisted UV spectrophotometric and RP-HPLC methods are presented for the simultaneous determination of tolperisone hydrochloride (TOL) and diclofenac sodium (DIC) from their combined phar...

Clinical Trials [2299 Associated Clinical Trials listed on BioPortfolio]

A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety...

Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions

- Objective: - To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administer...

Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertralin...

Maintenance Study for Adolescent Depression

This study examined the benefit of continued treatment with an antidepressant medication, sertraline, in adolescents with depression who improved on sertraline acutely. We hypothesize tha...

Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with [11C] sertraline positron emission tomography (PET) study.

Medical and Biotech [MESH] Definitions

Validation of the SEX of an individual by inspection of the GONADS and/or by genetic tests.

Validation of the SEX of an individual by inspection of the GONADS and/or by genetic tests.

Validation of the sex of an individual by means of the bones of the SKELETON. It is most commonly based on the appearance of the PELVIS; SKULL; STERNUM; and/or long bones.

Polymers of N-SUBSTITUTED GLYCINES containing chiral centers at the a-position of their side chains. These oligomers lack HYDROGEN BONDING donors, preventing formation of the usual intrachain hydrogen bonds but can form helices driven by the steric influence of chiral side chains.

A selective serotonin uptake inhibitor that is used in the treatment of depression.

Search BioPortfolio:
Loading