Determination of Ranitidine in Human Plasma by SPE and ESI-LC-MS/MS for Use in Bioequivalence Studies

Karini B Bellorio,Maria Isabel R Alves,Nelson R Antoniosi Filho

doi:10.1155/2013/484592

Karini B Bellorio, Maria Isabel R Alves + Show 1 more

Open Access

https://doi.org/10.1155/2013/484592

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Journal: ISRN Chromatography	Publication Date: Feb 4, 2013
Citations: 5	License type: CC BY 3.0

Affiliation: Universidade Federal de Goiás

Abstract

A method for determining ranitidine in human plasma by ESI-LC-MS/MS was validated, using propranolol as internal standard. The extraction method used was solid phase extraction (SPE). Chromatographic separation was performed in a Chromolith C18 (50 mm × 4.6 mm i.d.) analytical column, which provided good separation of ranitidine and propranolol peaks with an analysis time of 2.5 minutes. Extraction yields of 94.4% for ranitidine and 89.4% for the internal standard were obtained. The lower limit of quantification (LLOQ) was 3.00 ng/mL, and limit of detection (LOD) was 0.05 ng/mL, with linearity ranging from 3.00 to 500 ng/mL. The results, thus, showed that this method is suitable for application in bioequivalence studies of ranitidine in human plasma.

Highlights

E chemical structure of ranitidine hydrochloride (Figure 1) consists of a ve-membered furan heterocyclic ring and a nitroethenodiaminic group. e molecular mass of ranitidine hydrochloride is 350.9 daltons (g/mol), and its molecular formula is C13H22N4O3SHCl corresponding to hydrochloride N[2-[[[5-[(dimethylamine)methyl)-2-furan] methyl]thio]ethyl]-N′-methyl-nitro2-1,1-ethenodiamine
Extraction yields of 94.4% for ranitidine and 89.4% for the internal standard were obtained. e lower limit of quanti cation (LLO ) was 3.00 ng/mL, and limit of detection (LOD) was 0.05 ng/mL, with linearity ranging from 3.00 to 500 ng/mL. e results, showed that this method is suitable for application in bioequivalence studies of ranitidine in human plasma
Us, the object of this paper was to develop an analytical methodology for determining ranitidine in human plasma using the solid phase extraction (SPE) technique and high performance liquid chromatography coupled to mass spectrometry (HPLC-MS/MS) in order to develop a fast, highly speci c, and repeatable methodology for use in pharmaceutical bioequivalence studies

Summary

Introduction

E chemical structure of ranitidine hydrochloride (Figure 1) consists of a ve-membered furan heterocyclic ring and a nitroethenodiaminic group. e molecular mass of ranitidine hydrochloride is 350.9 daltons (g/mol), and its molecular formula is C13H22N4O3SHCl corresponding to hydrochloride N[2-[[[5-[(dimethylamine)methyl)-2-furan] methyl]thio]ethyl]-N′-methyl-nitro2-1,1-ethenodiamine. Ranitidine hydrochloride appears as a crystalline powder, practically odorless and white to light yellow. It is very soluble in water, somewhat soluble in alcohol, and slightly soluble in chloroform. Us, several methods for determining ranitidine in human plasma have been reported. Us, the object of this paper was to develop an analytical methodology for determining ranitidine in human plasma using the solid phase extraction (SPE) technique and high performance liquid chromatography coupled to mass spectrometry (HPLC-MS/MS) in order to develop a fast, highly speci c, and repeatable methodology for use in pharmaceutical bioequivalence studies. E stock solutions of ranitidine and propranolol were prepared at a concentration of 0.5 mg/mL in methanol : water (50 : 50 v/v). All solutions were placed in Falcon-type tubes. e tubes with the ranitidine solutions were protected from light with aluminum foil and stored in a freezer at −20∘C. e other solutions were stored in a refrigerator at +4∘C and replaced daily

Experimental

Results and Discussion

Method Validation

Conclusions