This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-Non Commercial-
ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is
given and the new creations are licensed under the identical terms.
© 2018 Journal of Advanced Pharmacy Education & Research | Published by SPER Publication 9
Validation parameters of densitometric method for simultaneous
determination of Galantamine hydrobromide and Pymadine
Dobrina Tsvetkova
1*
, Stefka Ivanova
1
1
Medical University-Sofia, Faculty of Pharmacy, Department of Pharmaceutical Chemistry, 2 Dunav Str., Sofia 1000, Bulgaria
Correspondence: Dobrina Tsvetkova, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Medical University-Sofia, Dunav str. N: 2, 1000, Sofia, Bulgaria.
E mail: dobrinka30 @ mail.bg
ABSTRACT
The aim of the current investigation was the development and validation as per ICH requirements of the TLC-densitometric method
with the detection at λ = 282 nm for the simultaneous determination of Galantamine hydrobromide and Pymadine in model mixtures.
The aim was in accordance to the perspectives of multi-target therapy of Alzheimer’s disease, and due to the fact that in the literature
and pharmacopoeial articles the methods for simultaneous analysis of these components haven’t been described. Selectivity was
confirmed by the fact that in blank solution, Rf data weren’t observed corresponding to Rf data of the active ingredients. The
regression equations obtained demonstrated the linear relationship between the peak area and concentration: y = 2.10
7
.x + 25364
(Galantamine hydrobromide) (LOD = 1.87.10
-3
g/ml; LOQ = 6.22.10
-3
g/ml); y = 2.10
7
.x + 65930 (Pymadine) (LOD = 2.5.10
-3
g/ml; LOQ = 8.35.10
-3
g/ml). All the experimental data for the degree of recovery were included in the corresponding confidence
interval: 93.54 % ÷ 97.32 % (Galantamine hydrobromide); 100.05 % ÷ 103.11 % (Pymadine). The results of precision suited the
relevant intervals.
System suitability was confirmed by the lack of a statistically significant difference between the Rf values: 0.663 (Galantamine
hydrobromide); 0.433 (Pymadine). The method was appropriate for the simultaneous determination of Galantamine hydrobromide
and Pymadine in the model mixtures.
Keywords: Densitometry, Galantamine, Pymadine, validation, determination.
Introduction
Alzheimer is a neurodegenerative disease
[1]
associated
with plaques and tangles in the brain
[2]
. The conventional
therapy is with Galantamine (Fig. 1.), Donepezil and
Rivastigmine
[3]
. A potent inhibitory activity against
acetylcholinesterase possess the extracts of Ocimum sanctum
[4]
and Cinnamon zeylanicum
[5]
.
In Alzheimer’s disease
[6]
, Galantamine improves the behavior
[7]
by blocking the reversible enzyme acetylcholinesterase and
allosterically potentiation of α7-nicotinic acetylcholine
receptors
[8]
, and improves learning and memory alone and in
combination with Pymadine
[9]
.
Reactive oxygen species induce neurodegeneration in
Alzheimer's disease
[10]
, and Galantamine is appropriate for the
treatmennt due to the antioxidant properties
[11]
.
4-aminopyridine (Dalfampridine) (Fig. 1.), has been a drug for
the symptomatic management of the multiple sclerosis
[12]
and it
improves walking
[13]
.
Figure 1. Chemical structures of Galantamine hydrobromide
and 4-aminopyridine.
For the analysis of Galantamine in Nivalin, HPLC has been
applied
[14]
. By High Performance Thin Layer Chromatography
(HPTLC), Gallic acid, Curcumin and Quercetin are analysed
[15]
. TLC is often applied for the analysis of plant extracts:
Psidium guajava
[16]
, Nelumbo nucifera
[17]
, Galantamine in
Access this article online
Website:www.japer.in E-ISSN: 2249-3379
How to cite this article: Dobrina Tsvetkova, Stefka Ivanova.Validation
parameters of densitometric method for simultaneous determination of
Galantamine hydrobromide and Pymadine. J Adv Pharm Edu Res 2018;8(4):9-
14.
Source of Support: Nil, Conflict of Interest: None declared.
Original Article