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Simple UV spectrophotometric assay of Amlodipine

Article · October 2014

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American
American Journal of Chemistry and Application
2014; 1(4): 66-69
Published online September 30, 2014 (http://www.aascit.org/journal/ajca)

Simple UV spectrophotometric
assay of Amlodipine
Safila Naveed*, Hina Qamar, Wardha Jawaid, Urooj Bokhari
Jinnah University for Women, Karachi, Pakistan

Email address
safila117@yahoo.com (S. Naveed), safila117@gmail.com (S. Naveed)

Citation
Safila Naveed, Hina Qamar, Wardha Jawaid, Urooj Bokhari. Simple UV Spectrophotometric
Assay of Amlodipine. American Journal of Chemistry and Application.
Vol. 1, No. 4, 2014, pp. 66-69.

Keywords Abstract
Amlodipine, Amlodipine besylate is a potent long-acting calcium channel blocking agent.. An
Assay, efficient least time consuming and simple spectrophotometric method for the assay of
UV Spectrophotometer Amlodipine has been used. The assay is based on the ultraviolet UV absorbance
maxima at about 238nm wavelength of Amlodipine using water as solvent. A sample
of drug was dissolved in water to produce a solution containing Amlodipine.
Similarly, various dilutions were made. The absorbance of sample preparation was
Received: August 28, 2014 measured at 238nm against the solvent blank and the assay was determined. In our
Revised: September 16, 2014 study a simple and quick assay method using U.V spectrophotometer has been used.
Accepted: September 17, 2014 The assay is based on measuring the absorbance of formulation of Amlodipine
dilutions at the wavelength of 238 nm. Four different dilutions of 50ppm, 25ppm,
12.5ppm and 6.25ppm are prepared and their percent assay is calculated.

1. Introduction
Amlodipine besylate is a potent long-acting calcium channel blocking agent. [1]
Amlodipine, a charged dihydropyridine-type (DHP) calcium channel blocker (CCB),
has been widely used to treat angina and HTN. By several meta-analyses it has been
evaluated that the effect of CCBs on cardiovascular outcomes. [2] [3] [4] Calcium
channel blockers [CCB] are one of the most widely used anti-hypertensive agents.
Amlodipine belongs to dihydropyridines CCB with long half-life (30-58 hrs) and
large volume of distribution (21 L/Kg)... [5] [6] A class of drugs that act by selective
inhibition of calcium influx through cell membranes or on the release and binding of
calcium in intracellular pools. Since they are inducers of vascular and other smooth
muscle relaxation. It is more effective than β-blockers in the treatment of variant
angina because it prevents and reverses the coronary spasms resulting in increased
blood flow and myocardial oxygen supply. [7] [2] Moreover, it inhibits selectively
the arterial vascular smooth muscle cell proliferation resulting in prevention of the
progressive narrowing of the arteries. [8] [9] Amlodipine besylate is official in British
Pharmacopoeia (BP). [10] Amlodipine is a chiral calcium antagonist, currently on the
market and in therapeutic use as a racemate [1:1 mixture of (R)-(+) - and (S)-(–)-
amlodipine[19]
Literature survey reveals quantitative determination of Amlodipine by liquid
chromatography[11], RP-HPLC method [18] ,automated gas chromatography[12],
HPLC with fllourescence detection[13], in human plasma by gas chromatography,
liquid chromatographic–tandem mass spectrometric method (LC-MS)[14][16] HPLC
[15] and Coupled-column chromatography on a Chiral-AGP phase for determination
of amlodipine enantiomers [17].
The aim of our present study was to calculate the percent assay different brands of
67 Safila Naveed et al.: Simple UV Spectrophotometric Assay of Amlodipine

Amlodipine. Efficient spectrophotometric method for the


assay of Amlodipine has been used. This method was
sufficiently good accurate, precision and permitted a simple
and cost effective assay of the compound in its dosage form.

2. Experimental
UV visible 1601 Shimadzu double beam
spectrophotometer was used to measurement of spectra.
The solvent which are used for the assay was water.
2.1. Wavelength Selection
Fig 1. Linearity plot for assay of different dilutionss of Lodopin
About 50 ppm of Amlodipine besylate solution was
accurately prepared in water. These solutions were scanned
in the 200-400 nm UV regions. The wavelength maxima
(max) were observed at 238 nm and this wavelength was
adopted for absorbance measurement.
2.2. Standard Stock Solution of Different
Brands

The five different brands of Amlodipine besylate, 5mg


Amlocard (PharmaTech), Novasc (Pfizer), Lodopin
(Merck), Zodip (Zafa pharmaceutical), Revloc (Opal
lab)and Ampress (BARRETT HODGSON PAKISTAN Fig 2. Linearity plot for assay of different dilutionss of Norvasc
(PVT) LTD) was purchased from different pharmacies in
Karachi, Pakistan. All tablets of each brand have same
batch number. All the five brands have 5 year shelf life.
Each brand equivalent to 5 mg of Amlodipine besylate was
transferred in a volumetric flask containing small water
then solution was sonicated for about 5 min and than make
up volume upto 100 ml with water.Same procedure was
repeat for all brands for preparation of solutions.
2.3. Dilutions Preparation

Four dilutions of 50 ppm, 25ppm, 12.5ppm and 6.25ppm


were made from 100ppm sample of Amlodipine besylate Fig 3. Linearity plot for assay of different dilutionss of Onato
solution.

3. Procedure
After preparation of stock solutions, strength of solution
100 ppm in 100 ml absorbance of the sample preparation
and transfer 25ml, 12.5ml, 6.25ml and 3.25ml in
volumetric flask and make up the volume upto 50ml to
make dilution and then transfer it in 1cm cell at the
wavelength of maximum absorbance at about 238nm, using
a spectrophotometer, using the blank solution.
Fig 4. Linearity plot for assay of different dilutionss of Zodip
American Journal of Chemistry and Application 2014; 1(4): 66-69 68

6.25pmm). Their percent assay is calculated and regression


equation and regression line is obtained . For detect
linearity solutions of 100ppm, 50ppm, 25ppm, 12.5ppm
and 6.25pmm is prepared and three absorbances in
triplicate were taken at each level in spectrophotometric
analysis. For linearity plot concentration vs. absorbance at
level 100ppm, 50ppm, 25ppm, 12.5ppm and 6.25pmm of
each brand is shown in fig 1, fig 2, fig 3, fig 4 and fig 5.
Squared correlation coefficient of each brand is shown in
table no 1. It should not be less than 0.99. Squared
correlation coefficient value of all the brands of Glimepride
Fig 5. Linearity plot for assay of different dilutionss of Ampress are well within the limit. All five brands of Amlodipine
showed linear relation with their dilution as the
4. Result and Discussion concentration decreases their absorbance are also decreases
as shown in table no 2. Our research group has done these
A simple and reliable UV method for quantitating types of assay for different commonly used generic and
amlodipine besylate in different pharmaceutical dosage their brands.These studies are very helpful for
formulation has been successfully developed. The limit of paharmacist ,doctors and drug prescribers to choose best
quantification, small sample volume and short analysis time drug[20-29].
of this method are particularly adapted for routine assay.
The results were in acceptable limit according to ICH Table 1. Regression equation and Correlation Coefficient of different
brand of Amlodipine
guidelines. The short analysis time enables its application
in routine and quality control analysis of finished products. Brands Strenght
Regression Corelation
Pharmaceutical assay was carried out by using Equation Coefficient
spectrophotometer on different brands of Amlodipine such Lodopin 5mg y=0.03x-0.012 R2=0.998
as Amlocard (PharmaTech), Novasc (Pfizer), Lodopin Norvasc 5mg y=0.029x-0.023 R2=0.999
Onato 5mg y=0.029x-0.035 R2=0.999
(Merck), Zodip (Zafa pharmaceutical), Revloc (Opal)
Zodip 5mg y=0.026x-0.016 R2=0.999
Ampress (BARRETT HODGSON PAKISTAN (PVT) LTD)
Ampress 5mg y=0.025x-0.027 R2=0.998
available in Pakistan. Four different dilutions of each brand
were prepared (100ppm, 50ppm, 25ppm, 12.5ppm and
Table 2. Absorbance Of Different Brands With Different Dilutions

Absorbance In Different Concentration


Brands Average Wt of Tablet in 10mg
100ppm 50ppm 25ppm 12.5ppm 6.25ppm
Lodopin 260mg 2.954 1.54 0.77 0.33 0.15
Norvasc 400mg 2.916 1.45 0.73 0.34 0.15
Onato 300mg 2.876 1.44 0.677 0.33 0.15
Zodip 400mg 2.595 1.25 0.625 0.325 0.152
Ampress 500mg 2.5 1.25 0.66 0.23 0.14

[2] Costanzo P, Perrone-Filardi P, Petretta M, et al. (2009)


5. Conclusion Calcium channel blockers and cardiovascular outcomes: a
meta-analysis of 175,634 patients. J Hypertens ;27:1136–
The UV spectrophotometric method proposed for the 1151.
determination of Amlodipine in tablets formulation. The
[3] Pahor M, Psaty BM, Alderman MH, et al.(2000) Health
aim of this work was to validate a simple, rapid and less outcomes associated with calcium antagonists compared
environmental toxic method to assay in different brands of with other first-line antihypertensive therapies: a meta-
amplodipiene by UV spectrophotometry. A good linear analysis of randomised controlled trials. Lancet.;356:1949–
relationship was observed for different concentrations 1954.
ranges of 100ppm, 50ppm, 25ppm, 12.5ppm and [4] Blood Pressure Lowering Treatment Trialists' Collaboration.
6.25ppm.Squared correlation coefficient value of each Turnbull F, Neal B. et al.(2008) Effects of different regimens
brand is well within the limit and the %assay lies within in to lower blood pressure on major cardiovascular events in
the standard BP and USP limits i.e 95-105%. older and younger adults: meta-analysis of randomised trials.
BMJ;336:1121–1123.

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