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B. Estimation of Paracetamol utilizing uv spectrophotometry

Paracetamol was estimated utilizing phosphate buffer pH 5.8 and measured at 257nm utilizing UV Spectrophotometry. It obeyed the Beer ‘s jurisprudence in the scope of 2-10 µg/ml. Slope was found to be 0.0445, and the correlativity coefficient was found to be 0.9978 and consequences were given in table 2.

Table 2: Appraisal of Paracetamol measured at 257nm utilizing UV Spectrophotometry.

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S.No

Concentration ( µg/ml )

Optical density at 257nm

1

0

0.0000

2

2

0.1006

3

4

0.2016

4

6

0.2687

5

8

0.3622

6

10

0.4657

Fig 1: Appraisal of Paracetamol measured at 257nm utilizing UV Spectrophotometry.

c. Compatibility surveies

Fig 2: IR spectrum of Paracetamol

Fig 3: IR spectrum of Aloe Vera

Fig 4: IR spectrum of Paracetamol and Aloe Vera

Table 3: IR spectrum of Paracetamol, Aloe Vera and Physical mixture

Materials

Wave figure ( cm-1 )

Peak for functional group assignment

Standard

Trial

PARACETAMOL

1501 ( m )

1502.13

Aromatic C=C stretching

1350-1280

1322.93

Aromatic secondary C-N quiver

1900-1600

1652

C-O stretching

1410-1310

1371.14

OH bending

1500-1300

1436.71

Aliphatic C-H bending

1650-1550

1562.06

Secondary NH bending

840-800

800.31

Aromatic C-H bending

ALOE VERA

1900-1600

1633.41

C-O stretching

3700-3000

3654.44

OH stretching

1500-1300

1403.92

C-H bending in plane

1300-800

1079.94

C-C stretching

Materials

Wave figure ( cm-1 )

Peak for functional group assignment

Standard

Trial

PARACETAMOL

+

ALOE VERA

1900-1600

1652.7

C-O stretching

1501 ( m )

1506.06

Aromatic C=C stretching

1500-1300

1438.64

Aliphatic C-H bending in one plane

840-800

804.17

Aromatic C-H bending

There was no interaction between drug and Aloe Vera gel and besides no interaction was established between drug and amylum every bit good as with other excipients. This can be predicted on the footing of no alteration in extremum in the characteristic Fourier Transformation Infrared Spectroscopy.

II. FORMULATION OF PARACETAMOL TABLET

Table 4: Tablet preparation incorporating Paracetamol with Aloe Vera gel in different concentration utilizing maize amylum as disintegrating agent

Ingredients

F1

( milligram )

F2

( milligram )

F3

( milligram )

F4

( milligram )

F5

( milligram )

F6

( milligram )

Paracetamol

500

500

500

500

500

500

Maize amylum paste

40

Aloe Vera gel

40

50

60

70

80

Maize amylum pulverization

70

70

70

70

70

70

Lactose

38

38

28

18

8

Magnesium stearate

2

2

2

2

2

2

Entire weight

650

650

650

650

650

650

Table 5: Tablet preparation incorporating Paracetamol with Aloe Vera gel in different concentration utilizing high concentration of Sodium amylum glycolate as disintegrating agent

Ingredients

F7

( milligram )

F8

( milligram )

F9

( milligram )

F10

( milligram )

F11

( milligram )

Paracetamol

500

500

500

500

500

AloeVera gel

40

50

60

70

80

Sodium amylum glycolate

70

70

70

70

70

Lactose

38

28

18

8

Magnesium stearate

2

2

2

2

2

Entire weight

650

650

650

650

650

Table 6: Tablet preparation incorporating Paracetamol with Aloe Vera gel in different concentration utilizing low concentration of Sodium amylum glycolate as disintegrating agent

Ingredients

F12

( milligram )

F13

( milligram )

F14

( milligram )

F15

( milligram )

F16

( milligram )

Paracetamol

500

500

500

500

500

AloeVera gel

40

50

60

70

80

Sodium amylum glycolate

36

36

36

36

36

Lactose

72

62

52

42

32

Magnesium stearate

2

2

2

2

2

Entire weight

650

650

650

650

650

III. EVALAUTION OF PARACETAMOL GRANULES

As per the consequences of physical word picture, batches from F1 to F16, the values ranged within that of the Pharmacopoeial bounds. These physical parametric quantities lead to the fact that such type of dose signifier can be easy formulated, utilizing the method involved, with no loss of stuff during packaging and transit.

Table 7: Evaluation of Granules

Parameters

F1

F2

F3

F4

F5

F6

F7

F8

Bulk denseness ( g/ml )

0.45

0.31

0.45

0.26

0.22

0.24

0.29

0.22

Tapped denseness ( g/ml )

0.55

0.35

0.55

0.29

0.28

0.29

0.31

0.28

Hausners ratio

1.22

1.14

1.22

1.11

1.28

1.13

1.06

1.28

Compressibility as per Carrs index ( % )

18.19

12.60

18.19

10.5

21.10

12.27

5.76

21.10

Angle of rest ( 0 )

35.86

34.20

36.54

36.76

34.24

39.14

32.16

35.42

Parameters

F9

F10

F11

F12

F13

F14

F15

F16

Bulk denseness ( g/ml )

0.25

0.45

0.22

0.45

0.24

0.29

0.22

0.22

Tapped denseness ( g/ml )

0.29

0.53

0.28

0.55

0.27

0.32

0.30

0.28

Hausner ratio

1.08

1.20

1.27

1.22

1.13

1.07

1.33

1.28

Compressibility as per Carr ‘s index ( % )

7.58

18.06

21.4

18.19

12.27

6.73

25.08

22.10

Angle of rest ( 0 )

32.16

36.86

35.42

33.60

32.14

32.28

37.21

36.19

IV. Evaluation of Paracetamol tablet

A. Thickness and Diameter

Table 8: Thickness and Diameter of Paracetamol tablets

S.No

Formulation codification

Thickness ( millimeter )

Diameter ( centimeter )

1

F1

4.64

1.27

2

F2

4.64

1.28

3

F3

4.59

1.27

4

F4

4.64

1.27

5

F5

4.59

1.28

6

F6

4.59

1.26

7

F7

4.59

1.28

8

F8

4.59

1.27

9

F9

4.64

1.27

10

F10

4.59

1.26

11

F11

4.64

1.26

12

F12

4.64

1.27

13

F13

4.64

1.27

14

F14

4.59

1.25

15

F15

4.64

1.27

16

F16

4.59

1.26

B. Weight Variation Test

. In weight fluctuation trial, the Pharmacopoeial bound ( United States Pharmacopoeia, 2000 ) for per centum divergence more than 324 milligram is ±5 % . The per centum divergence of all preparations was found to be within the bounds, and therefore all preparations passed the uniformity of weight as per official demands of the United States Pharmacopoeia, 2000. The consequences were shown in table 9.

Table 9: Weight Variation of Paracetamol tablets.

S.No

Formulation codification

Average weight ( milligram )

Limit scope ( ±5 % ) ( milligram )

1

F1

630

599-662

2

F2

656

623-689

3

F3

653

620-686

4

F4

645

613-677

5

F5

650

618-683

6

F6

644

611-676

7

F7

630

599-662

8

F8

650

618-683

9

F9

641

609-673

10

F10

652

619-673

11

F11

633

602-665

12

F12

641

609-673

13

F13

663

629-696

14

F14

656

632-689

15

F15

655

622-687

16

F16

649

616-681

C. Hardness Test

Formulated Paracetamol tablets were tested for hardness utilizing Pfizer hardness examiner. The hardness increased as the concentration of the binder increased. Batch F11 showed a maximal hardness of 6 kg/cm2 utilizing Aloe Vera as binding agent, whose hardness was similar to that of the mention batch F1. The consequences were shown in table 10.

Table 10: Hardness trial of Paracetamol tablets

S.No

Formulation codification

Hardness ( kg/cm2 )

1

F1

6.0

2

F2

3.6

3

F3

4.0

4

F4

4.6

5

F5

5.4

6

F6

6.0

7

F7

3.8

8

F8

4.4

9

F9

5.0

10

F10

5.2

11

F11

6.0

12

F12

3.2

13

F13

4.0

14

F14

4.6

15

F15

5.0

16

F16

5.6

Fig 5: Concentration of Binder versus Hardness

D. Friability Test ( Banker and Ander, 1987 )

Tablet hardness is non a complete indicant of strength. Tablet ‘s strength can besides be measured in footings of Friability. In the present survey, the per centum crumbliness for all the tablet preparations was found to be below 1 % , meaning that the crumbliness was found to be within the specified bounds. The crumbliness decreased with addition in concentration of the binder. The consequences were given in table 11.

Table 11: Friability trial of Paracetamol tablets.

S.No

Formulation codification

Friability ( % )

1

F1

0.157

2

F2

0.399

3

F3

0.334

4

F4

0.316

5

F5

0.284

6

F6

0.214

7

F7

0.468

8

F8

0.327

9

F9

0.204

10

F10

0.175

11

F11

0.126

12

F12

0.666

13

F13

0.458

14

F14

0.419

15

F15

0.256

16

F16

0.125

Fig 6: Concentration of Binder versus Friability

E. Wetting Time

The wetting clip of the tablets were given in table 12.

Table 12: Wetting clip of Paracetamol tablets

S.No

Formulation codification

Weting clip ( min )

1

F1

3

2

F2

5

3

F3

7

4

F4

8

5

F5

9

6

F6

12

7

F7

2

8

F8

4

9

F9

6

10

F10

8

11

F11

8

12

F12

6

13

F13

8

14

F14

9

15

F15

10

16

F16

14

Degree centigrades: UsersAnilaDesktopani projphotosImage077.jpg

Fig 7: Wetting clip of F1

Degree centigrades: UsersAnilaDesktopani projphotosImage079.jpg

Fig 8: Wetting clip of F11

Fig 9: Concentration of Binder versus Wetting Time

F. Disintegration Test

Disintegration trial was carried out for formulated tablets utilizing decomposition trial setup as prescribed in USP, 2000. The decomposition clip increased with addition in concentration of Aloe Vera gel. The decomposition clip was more with corns starch when compared to sodium amylum glycolate. The consequences of the decomposition trial were given in table 13.

Table 13: Decomposition trial of Paracetamol tablets

S.No

Formulation codification

Decomposition clip ( min )

1

F1

4

2

F2

6

3

F3

9

4

F4

10

5

F5

11

6

F6

14

7

F7

3

8

F8

6

9

F9

8

10

F10

9

11

F11

10

12

F12

7

13

F13

9

14

F14

10

15

F15

12

16

F16

15

Fig10: Concentration of Binder versus Disintegration Time

G. Drug Content Uniformity

Paracetamol tablets are tested for drug content as prescribed in IP, 2007. Good uniformity in content was found among different preparations. Percentage of drug content nowadays in the tablets was given in table 14.

Table 14: Drug content trial for Paracetamol tablets

S.No

Formulation codification

Sum of Paracetamol

Sum in milligram

Sum in per centum

1

F1

486

97.2

2

F2

500

100

3

F3

494

98.8

4

F4

498

99.6

5

F5

496

99.2

6

F6

484

96.8

7

F7

495

99

8

F8

494

98.8

9

F9

498

99.6

10

F10

499

99.8

11

F11

500

100

12

F12

501

100.2

13

F13

512

102.4

14

F14

489

97.8

15

F15

490

98

16

F16

496

99.2

H. IN-VITRO DISSOLUTION STUDIES

Figure 9 shows the disintegration profile of the prepared Paracetamol preparations. In-vitro drug release from the tablets was major regulating standards to make up one’s mind whether Aloe Vera gel or the commercially used binder ( amylum as in mention batch ) is good binding agent. The release profile for the drug was taken for a period of one an half hr which can outdo be depicted by graph between per centum drug release and clip. Batch F16 incorporating Aloe Vera gel as binder showed minimal release of 82.8 % as compared to other batches of Aloe Vera gel and against the tablets of mention batch ( Figure 11 ) .

Table 15: In-vitro Dissolution trial of Paracetamol tablets

Time ( min )

% Release F1

% Release F2

% Release F3

% Release F4

% Release F5

% Release F6

% Release F7

% Release F8

10

45

32

29.7

22.5

22.5

20.7

36.4

39.6

20

63

46.8

32.4

39.6

30.6

26.1

41.4

45

30

75

54

45.6

48.8

39.6

37.8

45

58.5

40

88.2

64.8

55.8

57.6

45

46.8

55.8

62.1

50

99.9

72

67.5

63

55.8

59.4

66.5

69.3

60

79.2

73.8

75.6

61.2

63

72

79.2

70

88.2

84.6

79.2

66.6

72

79.2

88.2

80

93.6

93.6

88.2

75.6

77.4

84.6

93.6

90

97.2

96.3

94.6

87.3

84.6

98

98.2

Time ( min )

% Release F9

% Release F10

% Release F11

% Release F12

% Release F13

% Release F14

% Release F15

% Release F16

10

32

27

22.5

27

26.1

21.6

19.8

17.1

20

39.6

36.4

33.2

32.4

30.6

27

26.1

29

30

45

45.9

42.3

39.6

39.6

32

33.2

37.8

40

59.4

52.2

48.6

45

48.6

45

41.4

50.4

50

63

58.5

53.1

59.4

59.4

50.4

57.6

55.8

60

73.8

68.4

64.8

64.8

63

62

63

64

70

81

79.2

72

73.8

75.6

75.6

70.2

70.2

80

88.2

82.8

81

88.2

84.6

82.8

77.4

77.4

90

95.4

89.1

86.4

96.3

94.6

89.1

85.5

82.8

Fig 11: In- vitro disintegration of Paracetamol tablets

I. KINETICS OF DRUG RELEASE

Assorted theoretical accounts such as Zero order dynamicss ( cumulative per centum sum of drug release against clip ) , First order dynamicss ( log cumulative per centum of drug staying to let go of against clip ) , Higuchi ( cumulative per centum sum of drug unreleased against square root of clip ) and Korsermeyer-Peppas ( log cumulative per centum of drug released against log clip ) were applied to measure the dynamicss of drug release from prepared Paracetamol tablets. Most suitable theoretical account for drug release was predicted on the footing of arrested development coefficient i.e. nearer the value of arrested development coefficient towards 1, greater the suitableness of best fitted release mechanism. In table 16, the kinetic parametric quantities for Paracetamol release utilizing Aloe Vera gel as adhering agent were presented. As clearly indicated in table 16, the in- vitro drug release from all the preparation follows Zero order dynamicss.

Table 16: Drug Release Kinetics of Paracetamol Tablets

Formulation codification

Zero Order

R2

First Order

R2

Higuchi Plot

R2

Korsemeyer Plot R2

F1

0.993

0.973

0.997

0.998

F2

0.980

0.924

0.996

0.996

F3

0.987

0.9083

0.973

0.956

F4

0.980

0.922

0.994

0.993

F5

0.993

0.904

0.973

0.983

F6

0.987

0.973

0.985

0.980

F7

0.985

0.666

0.948

0.927

F8

0.990

0.868

0.979

0.970

F9

0.970

0.976

0.896

0.993

F10

0.993

0.957

0.983

0.988

F11

0.994

0.946

0.980

0.991

F12

0.986

0.806

0.939

0.940

F13

0.993

0.849

0.956

0.958

F14

0.988

0.925

0.951

0.954

F15

0.989

0.957

0.971

0.971

F16

0.985

0.984

0.996

0.998

Fig 12: Dissolution KINETICS OF F1

Fig 13: Dissolution KINETICS OF F2

Fig 14: Dissolution KINETICS OF F3

Fig 15: Dissolution KINETICS OF F4

Fig 16: Dissolution KINETICS OF F5

Fig 17: Dissolution KINETICS OF F6

Fig 18: Dissolution KINETICS OF F7

Fig 19: Dissolution KINETICS OF F8

Fig 20: Dissolution KINETICS OF F9

Fig 21: Dissolution KINETICS OF F10

Fig 22: Dissolution KINETICS OF F11

Fig 23: Dissolution KINETICS OF F12

Fig 24: Dissolution KINETICS OF F13

Fig 25: Dissolution KINETICS OF F14

Fig 26: Dissolution KINETICS OF F15

Fig 27: Dissolution KINETICS OF F16

STABILITY STUDIES

Among all formulated Paracetamol tablets, preparation F6, F11 and F16 were selected and tested as per international conference on Harmonization guidelines. The preparations were stored at existent clip 30±20C/65±5 % RH trial conditions in stableness Chamberss for 6 months. At thethird month, the tablets were evaluated.

Table 17: Stability survey informations of Paracetamol tablet

Formulation codification

Thickness

( millimeter )

Hardness

( kg/cm2 )

Crumbliness

( % )

Decomposition

( min )

Drug content ( % )

Addition in weight ( % )

F6

F11

F16

4.61

4.66

4.62

5.8

5.8

5.4

0.318

0.334

0.284

12

8

13

96

99.8

98.8

0.523

1.213

0.923

. When tablets were kept at existent clip 30±20C/65±5 % RH storage status, the hardness and decomposition clip decreased bespeaking that the tablets were susceptible to friability loss. Therefore, the tablets must be protected from atmospheric wet.

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