J. Biomedical Science and Engineering, 2010, 3, 439-441 JBiSE
doi:10.4236/jbise.2010.34060 Published Online April 2010 (http://www.SciRP.org/journal/jbise/).
Published Online April 2010 in SciRes. http://www.scirp.org/journal/jbise
Estimation of the galanthamine using derivative
spectrophotometry in bulk drug and formulation
Karan Mittal1, Ramni Kaushal1, Rajashree Mashru2, Arti Thakkar1
1I. S. F. College of Pharmacy, Ferozepur Road, Ghal Kalan, Moga, Punjab, India;
2Center of Relevance and Excellence in Novel Drug Delivery Systems, Pharmacy Department, G.H. Patel Building, The Maharaja
Sayajirao University of Baroda, Vadodara, India.
Received 8 January 2010; revised 20 January 2010; accepted 23 January 2010.
ABSTRACT
Two simple, rapid, accurate, precise, reliable and eco-
nomical spectrophotometric methods have been pro-
posed for the determination of galanthamine hydro-
bromide (GH) in bulk and pharmaceutical formula-
tion. First method is zero order UV spectrophotometry
and second is 1st derivative zero crossing spectropho-
tometry. The developed methods have shown best re-
sults in terms of linearity, accuracy, precision, LOD
and LOQ for bulk drugs and marketed formulations.
Absorbance was measured at 287 nm for zero order
and 277.4 nm for first derivative. It obeyed Lam-
bert-Beer’s law in the range of 30-80 μg mL-1. Both
methods have good linearity (r2 = 0.9997) and accu-
racy found to be 100.5% and 101.2% for both methods
respectively.
Keywords: Galanthamine Hydrobromide (GH); Zero
Order UV-Spectrophotometry; First Derivative Zero
Crossing Spectrophotometry
1. INTRODUCTION
Figure 1 is the structure of galanthamine hydrobromide
(GH), which is (4 aS,6R,8aS)-5, 6, 9, 10, 11, 12-hexahydro-
3-methoxy-11-methyl-4aH-[1] benzofuro [3a,3,2-ef] [2]
benzazepin-6-ol [1,2]. It is used for the treatment of mild
to moderate Alzheimer’s disease and various memory
impairmen ts [3,4]. The mo lecular weight of GH is 3 68. 27
and melting point is 258-264°C. GH is very soluble in
water [5].
Figure 1. Structure of GH.
The official monograph of USP [6] describes assay
method for GH using HPLC but compare to that spec-
trophotometric methods are more economic and simple.
Under computer-controlled instrumentation, derivative
spectrophotemetry is playing a very importan t role in the
analysis of drugs by giving more resolved spectra than
the zero or der spect ra [7,8].
The aim of the present work is to investigate u tility of
derivative spectrophotometry and to develop reliable
spectrophotometric procedure for determination of GH
either in bulk and marketed formulation.
2. MATERIALS AND METHODS
2.1. Instruments and Reagents
Spectrophotometric measurements were made on a Shi-
madzu 1700 double beam UV-VIS spectrophotometer
with a fix slit width of 1 nm coupled with computer
loaded with Shimadzu UV PC software (UV probe) ver-
sion 2.31. Double distilled water was used and pure GH
was obtained from Alembic Pharmaceuticals Ltd. Vado-
dara, India. The marketed formulation of GH was ob-
tained commercially from Sun Pharmaceuticals Ltd
(Galmer-40 tablets labeled 4 mg of pure drug, Batch
Number-GK 90964).
2.2. Standard and Test Solutions
Stock solution of 1 mg mL-1 of pure GH and its formu-
lation was freshly prepared in double distilled water. Test
solution of GH was tested for stability in solution during
the actual analysis. The behaviour of GH was found to
be stable over the period of 24 hr from their preparation
at room temperature.
2.2.1. Zero Order UV-Spectrophotemetry (M ethod 1)
The working solutions were prepared by accurately di-
luting aliquots of the standard solution with water to
obtain the concen tration in range of 30-80 μg mL-1. The
absorption spectra of the samples were recorded between
200-400 nm against double distilled water using a 1.0 cm

K. Mittal et al. / J. Biomedical Science and Engineering 3 (2010) 439-441 440
quartz cell. Zero order spectra of pure drug GH were
stored individually within mentioned concentration ranges
and absorbance was measured at 280 nm.
2.2.2. First Derivative Zero Crossing
Spectrophotometry (Method 2)
The zero order absorption spectra of GH were derivatized
in first order using delta lambda 4 and scaling factor 10.
The first derivative amplitudes were recorded at 277.4 nm.
3. RESULTS AND DISCUSSION
The absorption spectra of the GH were recorded at
wavelength 287 nm for zero order UV-spectrophotometry
and 1st derivative was measured at 277.4 nm. It is ob-
served from the spectra that GH shows a good linearity
in the range of 30-80 μg mL-1. Figure 2 explains the
zero order spectra of GH. While, Figure 3 describes first
derivative spectra of GH which showed more resolution
than zero order spectra. Both methods were validated, all
the validation parameters were in limit as per the ICH
guidelines [9]. Table 1 exhibits the detailed validation
parameters for both the methods. Tabl e 2 represents re-
sults of recovery studies of both methods and Table 3
Figure 2. The zero order spectra of GH of 30-80 μg mL-1.
Figure 3. The first derivative spectra of GH of 30-80 μg
mL-1.
Table 1. Validation parameters obtained by method 1 and
method 2.
Parameters Method-1 Method-2
Linearity 0.9996 0.9997
Range (μg mL-1) 30-80 30-80
Accuracy 100.5 ± 2.39 101.2 ± 1.63
Precision % R.S.D-0.831 5 % R.S.D-1.705 2
LOD (μg mL-1) 1.46 0.72
LOQ (μg mL-1) 4.45 2.19
Assay (%Purity) 98.02 99.94
Tabl e 2. The results of recovery studies of the method 1 and
method 2.
Amt added
(μg mL-1) % Recovery
Method 1 % Recovery Method 2
16 99.25 101.6
20 99.05 99.4
24 103.3 102.6
Mean recovery 100.5 101.2
SD 2.39 1.63
Ta ble 3. The statistical comparison of the results of validated
methods.
t-Test F-Test
tcalculated = 0.419 Fcalculated = 2.14
ttheoretical = 3.52 Ftheoretical = 19.0
explains the statistical comparison of results of both the
validated methods.
The results obtained were compared statistically by
Student t-test and by the variance ratio F-test with those
obtained by each method. The calculated values of the
Student t-values at 95% confidence level and the vari-
ance ratio F-values did not exceed the theoretical values
indicating that there were no significant differences
among the results of the developed two methods.
4. CONCLUSIONS
The developed spectrophotometric methods for deter-
mination of GH are simple, specific, accurate, precise,
rapid and economical which indicates its adequacy for
routine pharmaceutical analysis. It is concluded that de-
rivative spectrophotometry is successfully utilized for
the estimation of GH.
5. ACKNOWLEDGEMENT
The authors express their sincere thanks to Mr Bhagirath Patel, F & D
Division, Alembic Pharmaceuticals Ltd. Vadodara, India for supplying

K. Mittal et al. / J. Biomedical Science and Engineering 3 (2010) 439-441 441
gift samples of pure Galanthamine hydrobromide and also I.S.F Col-
lege of Pharmacy, Moga for providing facilities to carry out the re-
search.
REFERENCES
[1] Ping, J., Rong, S., Jing, Z., Liang, F., Qiaojun, H. and
Yongzhou, H. (2008) Design, synthesis and evaluation of
galanthamine derivatives as acetylcholinesterase inhibi-
tors. European Journal of Medicinal Chemistry, 44 (12),
772-784.
[2] Traykova, M., Traykov, T., Hadjimitova, V., Krikorian, K.
and Bojadgieva, N. (2003) Antioxidant Properties of Gal-
antamine Hydrobromide. Zeitschrift für Naturforschung, 58c,
361-365.
[3] Heinrich, M. and Teoh, H.L. (2004) Galanthamine from
snowdrop-the development of a modern drug against
Alzheimer's disease from local Caucasian knowledge.
Journal of Ethno pharmacology, 92, 147-162.
[4] Scott, L.J. and Goa, K.L. (2000) Galantha mine: A re-
view of its use in Alzheimer's disease. Adis Review, 60(5),
1095-122.
[5] Novikova, I.Y. and Tulaganov, A.A. (2002) Physico-
chemical methods for the analysis of galanthamine (re-
view). Pharmaceutical Chemistry Journal, 36(11), 623-627 .