Open Access Research Article
Analytical & Bioanalytical
Techniques
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ISSN: 2155-9872
Hamd et al., J Anal Bioanal Tech 2016, 7:1
http://dx.doi.org/10.4172/2155-9872.1000294
Volume 7 • Issue 1 • 1000294
J Anal Bioanal Tech
ISSN: 2155-9872 JABT, an open access journal
Keywords: Non-aqueous titration; Loratadine; Acetous perchloric
acid; Acetous crystal violet; Some pharmaceutical preparations
Introduction
H1-antihistamines antagonists were classified into six groups;
alkylamines, monoethanolamines, ethylenediamines, phenothiazines,
piperazines, and piperidines [1]. Loratadine (LOR, Figure 1), chosen
for the current study, an 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]
cyclohepta[1,2-b]pyridine-11-ylidene)-1-piperidinecarboxylic
acid ethyl ester [2,3], crystals from acetonitrile with melting point
134 to 136°C, soluble in alcohol (1 in 10); insoluble in water with a
dissociation constant (pKa) 5.0. LOR is belonged to a non-sedating
peripheral histamine H1 receptor antagonist, a last generation of
H1-antihistamine drugs used to treat allergies, marketed for its non-
sedating properties [4].
e aim of the present study was firstly, to find out a rapid method
which could be conveniently used for the determination of the
percentage purity of a weak bases and insoluble drugs such as LOR
(pK
a
=5.0) in raw material and also in pharmaceutical preparations.
Secondly, to discover again the old-fashion, robust, accurate and
precise technique of non-aqueous titration, specially the quantitative
determination in the concentration range of the developed procedure.
A review outlined the previously reported quantitative volumetric
and instrumentation methods for determination of LOR and other
antihistaminic antagonists analogues was prepared by El-Kommos et
al. [1]. e chemical reaction and titrimetric variables were studied
and optimized on the basis of lower determined concentrations,
temperature, and reagents consumption, and the results obtained by
the proposed titrimetric method were comparable with those obtained
by an instrumental reported method [5].
Experimental
Materials
LOR tablets, suspensions (were claimed to contain 5 and 10 mg
respectively for tablets and suspensions) and pure LOR standard drug
were kindly supplied by Medical Union Pharmaceuticals (MUP, Cairo,
Egypt). Glycerin incorporated-LOR nanoparticles were prepared in the
laboratory of pharmaceutics department, Faculty of Pharmacy, Al Azhar
University (Assuit, Egypt). Glacial acetic acid (CH
3
COOH), perchloric
acid (HClO
4
, 70% w/v) and crystal violet powder were obtained from
El Nasr Chemical Co., (Abu Zaabal, Egypt). All chemicals used through
the study were of analytical reagent grade.
Methods
Preparation of perchloric acid and crystal violet solution:
*Corresponding author: Ahmed A. H. Abdellatif, Department of Pharmaceutics
and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Assuit 71524,
Egypt, Tel: +201016660069; E-mail: ahmed.a.h.abdellatif@azhar.edu.eg
Received December 11, 2015; Accepted December 28, 2015; Published January
26, 2016
Citation: Hamd MAE, Ali R, Abdellatif AAH (2016) Non-Aqueous Titrimetric Assay
for Determination of Loratadine in Pharmaceutical Preparations. J Anal Bioanal
Tech 7: 294. doi:10.4172/2155-9872.1000294
Copyright: © 2016 Hamd MAE, et al. This is an open-access article distributed
under the terms of the Creative Commons Attribution License, which permits
unrestricted use, distribution, and reproduction in any medium, provided the
original author and source are credited.
Abstract
Non-aqueous titrations is the most titrimetric procedure used in pharmacopoeial assays and serves a double
purpose, as it suitable for the titration of weak acids and bases and provides a solvent in which organic compounds
are soluble. A simple, cost-effective, rapid, and precise method for determination of loratadine (LOR) in pure and
pharmaceutical dosage forms was developed. The method based on non-aqueous titration using acetous perchloric
acid as a titrant and acetous crystal violet as indicator. All measurements are carried out by running simultaneous
blank determinations and the final titer values are subtracted from blank to get actual amount of acetous perchloric acid
equivalent to LOR. The method was successfully applied for determination of LOR in pure and some pharmaceutical
preparations. The percentage recoveries of the proposed method were ranged from 84.8 ± 0.1% to 100.9 ± 0.1%.
The method showed an acceptable precision and accuracy as it able to determine LOR in presence of the different
excipients present in some commercial preparations without any significant interference.
Non-Aqueous Titrimetric Assay for Determination of Loratadine in
Pharmaceutical Preparations
Mohamed A El Hamd
1
, Ramadan Ali
1
and Ahmed A H Abdellatif
2
*
1
Department of Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut 71524, Egypt
2
Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University, Assiut 71524, Egypt
N
O CH
3
O
N
Cl
Figure 1: Chemical structure of LOR.