Simple UV Spectrophotometric Assay of Atorvastatin API Formulation and their Comparative Study

Table of contents

1. Introduction

torvastatin figure 1 is an HMG-CoA reductase inhibitors (3-hydroxy,3-methylglutaryl-CoA), called statins. It was a breakthrough for the prevention of hypercholesterolemia and related diseases.1-3 Cholesterol has an important role in the daily functioning of the body. But, it can also have a negative effect to the development of atherosclerosis. These plaques can block the arteries, disturb blood flow, or may rupturing and causing a clot that increases blockage. The results of these blockages are very serious and can cause angina, claudication, stroke and heart attack.4 Hyperlipidemia and hypertension are correlated to each other and have additional effect on CHD coronary heart disease and associated mortality rate, since CV cardiovascular disease is closely related to some factors such as high cholesterol levels, hypertension or diabetes. In literature there are many evidences which suggest additive beneficial effects of statin combined with losartan in the treatment of hypercholesterolemia, hypertensive patients.5

There are several methods reported by HPLC with the statin 6-10 but there is study found that show the comparison of available brands in market.Because the therapy is very expensive an person who has any cardiovascular disorder take medicine life time when he started.Therefor it is important that they use medicine should not be expensive and give hundred % result.

Author: Faculty of Pharmacy Jinnah University for Women Karachi. e-mail: [email protected] There for in the mind of this I have checked the % assay of different brands available in the market .

The aim of this study is to investigate the assay of commercially available six brands of atorvastatin in Karachi, Pakistan. number and were labeled to conatin atorvastatin 10mg per tablet. All the six brands have 5 year shelf life.

The serial number as an identification of purchased brands are given in Tabel 1.20 tablets of six different brand of atorvastatin from the marketed sample were weighed and crushed uniformly with the help of a mortar and pestle. By calculating the average weighed sample powder equivalent to 10 mg of atorvastatin was transferred into a volumetric flask containing 10mL methanol solvent MeOH. The solutions were sonicated for about 5 min and than make up volume upto 100 ml with water.

2. d) Procedure

After preparation of standard and tablet solutions, strength of solution 100 ppm in 100 ml absorbance of the sample preparation and standard preparation in 1cm cell at the wavelength of maximum absorbance at about 244 nm, using spectrophotometer, using the blank solution. Calculate the quantity in mg, of atorvastatin per tablet.

3. III.

4. Results and Discussions

Pharmaceutical assay was carried out by using spectrophotometer on all brands of atorvastatin tablets during the study. Table-1 shows name brand and % assay of different brands. Table-2 ,3 are showing the descriptive within and between groups and shows result are highly significant with p value 0.000.

Test of hypothesis i-e ANOVA and multiple comparison of different brands of atorvastatin are given in table 3 shows highly significant difference of all brands with each other. The proposed method for the assay of commercially available atorvastatin tablet formulation is very simple, accurate ,least time consuming and rapid. It can be easily used for routine quality control QC for monitoring the assay in the API, inprocess samples and tablet formulation. ANOVA shows between and within group F value 309348.804 with degree of freedom df value5 and 24 and p value 0.00 which shows significant results.

Figure 1. Figure 1 :
1Figure 1 : Structure of Atorvastatin II.
Figure 2. Table 1 :
1
Brand Name Serial no Average wt of tablet mg Wt for 100 ppm Absorbance 244 nm % assay
Prostatin ATR-1 16.43 16.43 0.157 104.66
Statin ATR-2 16.6 16.6 0.137 91.33
Fopsec ATR-3 15.9 15.9 0.099 66.00
Winstor ATR-4 15.6 15.6 0.118 78.66
Survive ATR-5 18.8 18.8 0.059 39.33
Figure 3. Table 2 :
2
Sum of Squares df Mean Square F Sig.
Between Groups 13328.351 5 2665.670 309348.804 .000
Within Groups .207 24 .009
Total 13328.557 29
Figure 1
Figure 4. Table 5 :
5
%Availability of
different brands
150
100
50
0
ATR- ATR- ATR- ATR- ATR- ATR-
1 2 3 4 5 6
ATR2 13.30467 * .05871 .000 13.1835 13.4258
ATR3 38.56733 * .05871 .000 38.4462 38.6885
ATR1 ATR4 25.96600 * .05871 .000 25.8448 26.0872
ATR5 65.29267 * .05871 .000 65.1715 65.4138
ATR6 42.53133 * .05871 .000 42.4102 42.6525
ATR1 -13.30467 * .05871 .000 -13.4258 -13.1835
ATR3 25.26267 * .05871 .000 25.1415 25.3838
ATR2 ATR4 12.66133 * .05871 .000 12.5402 12.7825
ATR5 51.98800 * .05871 .000 51.8668 52.1092
ATR6 29.22667 * .05871 .000 29.1055 29.3478
ATR3 ATR4 ATR1 ATR2 ATR4 ATR5 ATR6 ATR1 ATR2 ATR3 -38.56733 * -25.26267 * -12.60133 * 26.72533 * 3.96400 * -25.96600 * -12.66133 * 12.60133 * .05871 .05871 .05871 .05871 .05871 .05871 .05871 .05871 .000 .000 .000 .000 .000 .000 .000 .000 -38.6885 -25.3838 -12.7225 26.6042 3.8428 -26.0872 -12.7825 12.4802 -38.4462 -25.1415 -12.4802 26.8465 4.0852 -25.8448 -12.5402 12.7225 Global Journal of
ATR5 39.32667 * .05871 .000 39.2055 39.4478
ATR6 16.56533 * .05871 .000 16.4442 16.6865
ATR1 -65.29267 * .05871 .000 -65.4138 -65.1715
ATR2 -51.98800 * .05871 .000 -52.1092 -51.8668
ATR5 ATR3 ATR4 -26.72533 * -39.32667 * .05871 .05871 .000 .000 -26.8465 -39.4478 -26.6042 -39.2055
ATR6 -22.76133 * .05871 .000 -22.8825 -22.6402
1

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Notes
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Date: 2014-01-15