CHAPTER-5 RESULTS AND DISCUSSION

RESULTS

Melting point:

Melting point of Montelukast Sodium was determined by capillary method and results fount
to be 108-110˚ C, which complied with the standard monograph , indicating the purity of the
drug.

Solubility analysis:

Montelukast Sodium found to be soluble in water, ethanol and dimethyl formamide

Calibration curve of Montelukast Sodium:

Montelukast Sodium obey the Beer’s law in concentration range of 5-30 µg/ml in 0.5%

SLS with regression coefficients (R2) of 0.9987. The calibration data is given table and

calibration curve was constructed in graph no.1

Table No. 10: Calibration Curve of Montelukast Sodium in 240 nm.

S.N. Concentration (µg/ml) Absorbance (240nm)

1 0 0±0.00

2 5 0.156±0.015

3 10 0.293±0.001

4 15 0.460±0.012

5 20 0.583±0.016

6 25 0.769±0.062

7 30 0.898±0.014

Note: All values are expressed as mean ± SD. n=3.

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CHAPTER-5 RESULTS AND DISCUSSION

1
0.9
0.8
0.7
y = 0.0301x
0.6 R² = 0.9987
Absorbance

0.5
0.4
0.3
0.2
0.1
0
0 5 10 15 20 25 30 35
Concentration(µg/ml)

Graph No.1: Calibration curve of Montelukast Sodium at 240 nm

Drug and polymer compatibility studies

Drug and polymers are used to prepare oral dispersible tablet were checked for
compatibility study by carrying out FTIR spectroscopy. The FTIR spectra obtained for pure
drug and drug-polymers mixture from 4000 to 400 cm-1 are given as follows.

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CHAPTER-5 RESULTS AND DISCUSSION

Fig. No.9: FTIR spectra of Montelukast Sodium

100 95
Transmittance [%]
90 85
80

3850.41

2910.50

1633.79
1556.16
1495.03
1393.09

1219.80
1130.08
1067.11
1016.67
960.62
928.80
861.82
834.70
758.62
695.18
593.82
561.11
526.81
514.47
3500 3000 2500 2000 1500 1000 500
Wavenumber cm-1

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Fig. No. 10: FTIR spectra of Montelukast Sodium+ Crospovidone

100 95
Transmittance [%]
90 85
80

3268.37

1650.96
1556.14
1494.83
1417.49

1287.57

1129.62
1066.87

960.75

835.00
749.50
695.23
566.66
530.83
513.97

3500 3000 2500 2000 1500 1000 500

Wavenumber cm-1

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CHAPTER-5 RESULTS AND DISCUSSION

Fig. No. 11: FTIR spectra of Montelukast Sodium + Sodium Starch Glycolate

100 95
Transmittance [%]
90 85
80

3850.24

3732.37
3646.10

3248.68

1591.99
1556.42
1495.10
1404.46

1144.79

997.35
927.44
861.39
834.86
759.35
694.49
562.02
526.85
518.93
510.08
3500 3000 2500 2000 1500 1000 500
Wavenumber cm-1

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eco ZnSe

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Fig. No.12: FTIR spectra of Montelukast Sodium +Guar Gum

100
99
Transmittance [%]
97 96
9598

3893.32
3844.28
3827.21
3742.56
3677.09
3641.58

3245.33

2918.57

2358.49
2311.58

2130.39

1740.55
1642.35
1547.92
1493.15
1393.62

1243.78

1135.79
1061.07
1013.40
961.06
865.06
829.72
753.48
688.62
606.93
554.02
522.35

3500 3000 2500 2000 1500 1000 500

Wavenumber cm-1

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CHAPTER-5 RESULTS AND DISCUSSION

Fig .No. 13: FTIR spectra of Montelukast Sodium + Gellan Gum

100
98 96
Transmittance [%]
90 92 94
88
86

3231.06

2923.32

1547.24
1491.64
1394.34

1013.00
961.36
866.19
832.00
751.26

570.54
3500 3000 2500 2000 1500 1000 500
Wavenumber cm-1

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Fig .No. 14: FTIR spectra of Montelukast Sodium + Sterculia Gum

100
98 96
Transmittance [%]
90 92 94
88
86

3749.17

3229.20

2924.08

1592.74
1556.58
1495.22
1393.65

1011.69
964.07

835.27

571.56
552.36
523.07

3500 3000 2500 2000 1500 1000 500

Wavenumber cm-1

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CHAPTER-5 RESULTS AND DISCUSSION

Fig .No. 15: FTIR spectra of Montelukast Sodium + Cross povidone + Guar Gum

100
95
Transmittance [%]
90 85
80

3850.79

2894.33

1644.91
1556.71
1494.87
1462.37
1421.79
1288.01

1142.76

1014.11

864.22
835.46
577.52
566.07
540.78
531.46
516.44
504.11
3500 3000 2500 2000 1500 1000 500
Wavenumber cm-1

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Fig .No. 16: FTIR spectra of Montelukast Sodium + Cross povidone + Gellan Gum
100
98 96
Transmittance [%]
90 92 94
88
86

3851.20

3732.91
3686.98
3646.86

3242.08

2920.37

1644.82
1606.94
1556.88
1495.41
1417.38

1288.27

1018.61
963.78

834.26
612.74
548.33
533.14
519.02
509.58

3500 3000 2500 2000 1500 1000 500

Wavenumber cm-1

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CHAPTER-5 RESULTS AND DISCUSSION

Fig .No. 17: FTIR spectra of Montelukast Sodium + Cross povidone + Sterculia Gum

100
98 96
Transmittance [%]
90 92 94
88
86

3850.56

3742.13

3281.51

2916.51

1644.68
1556.51
1495.14
1418.21

1288.01

1017.08
964.96

835.14
585.21
557.59
534.73
527.81
516.29
509.77
3500 3000 2500 2000 1500 1000 500
Wavenumber cm-1

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Fig .No. 18: FTIR spectra of Montelukast Sodium + Sodium Starch Glycolate
+ Guar Gum
100
98
96
Transmittance [%]
90 92 88
86
8494

3898.55
3882.46
3851.43
3835.92
3815.65
3800.06
3748.31
3709.81
3687.09
3646.62
3626.56
3275.66

2915.59

2351.62
2337.16

1731.62
1660.24
1644.54
1633.86
1592.53
1574.46
1556.82
1538.91
1495.51
1404.68
1337.10
1145.37
999.01
862.69
834.66
759.93
693.44
666.57
619.60
592.62
562.28
547.83
528.24
515.88
506.24

3500 3000 2500 2000 1500 1000 500

Wavenumber cm-1

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CHAPTER-5 RESULTS AND DISCUSSION

Fig.No. 19: FTIR spectra of Montelukast Sodium + Sodium Starch Glycolate

+ Gellan Gum
100
98 96
Transmittance [%]
90 92 94
88
86

3266.50

1593.11

1404.99

1001.71

516.24
3500 3000 2500 2000 1500 1000 500
Wavenumber cm-1

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Fig.No. 20: FTIR spectra of Montelukast Sodium + Sodium Starch Glycolate

+ Sterculia Gum
100
98
Transmittance [%]
94 96
92
90

3229.09

1592.41
1495.52
1404.58

998.95

836.38

587.63
550.02
531.74

3500 3000 2500 2000 1500 1000 500

Wavenumber cm-1

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 CHAPTER-5 RESULTS AND DISCUSSION

Table No. 11: FTIR position of characteristic bond vibrations of pure drug Montelukast
Sodium and the drug with excipients.

S. Various Mode Observed FTIR Positions of various Bond-vibrations in Wavenumber (cm-1)

N of Bond
Pure Drug+Cro Drug+ Drug+Guar Drug+Gella Drug+Ste
vibrations and
drug spovidone SSG .G n. G r. G
Wavenumber
Range (cm-1)

1. N-H Stretching 3245.33 3268.37 3248.68 3245.33 3231.06 3229.20

(3000-3700)

2. C-H Stretching 2910.50 2910.50 2915.25 2918.57 2923.32 2924.08

(2700-3300)

3. C=O 1556.16 1650.96 1591.99 1642.35 1547.24 1592.74

Stretching

(1600-1900)

4. C-N Stretching 1130.08 1287.57 1144.79 1135.79 1145.55 1235.17

(1080-1360)

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 CHAPTER-5 RESULTS AND DISCUSSION

Table No. 12: FTIR position of characteristic bond vibrations of pure drug Montelukast
Sodium and the drug with excipients.

S. Various Mode Observed FTIR Positions of various Bond-vibrations in Wavenumber (cm-1)

N of Bond
vibrations and Drug+Cr Drug+Cros. Drug+Cro Drug+SSG. Drug+SSG Drug+SSG
Wavenumber os+Guar +Gellan G s.+ Ster. G +Guar G +Gellan G +Ster. G
-1
Range (cm ) G

1. N-H Stretching 3189.56 3242.08 3281.51 3275.66 3266.50 3229.09

(3000-3700)

2. C-H Stretching 2894.33 2920.37 2916.51 2915.59 2915.59 2925.50

(2700-3300)

3. C=O 1644.911 1644.82 1644.68 1644.54 1593.11 1592.42

Stretching

(1600-1900)

4. C-N Stretching 1142.76 1288.27 1288.01 1145.37 1142.76 1142.76

(1080-1360)

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 CHAPTER-5 RESULTS AND DISCUSSION

EVALUATION OF TABLETS OF ALL FORMULATIONS

Table no 13: Pre-compression parameters of Montelukast Sodium powder mixture

Formulation Bulk density Tapped density Carr’s Index Hausner’s Angle of

Batch (gm/cm3) (gm/cm3) (%) ratio repose (°)

F1 0.315±0.003 0.358±0.004 12.01±0.76 1.13±0.008 27.30±1.13

F2 0.303±0.001 0.342±0.006 11.40±0.14 1.12±0.003 28.20±1.08

F3 0.312±0.006 0.363±0.002 14.04±0.04 1.16±0.012 29.80±1.19

F4 0.310±0.003 0.359±0.003 13.64±0.06 1.15±0.007 27.90±1.08

F5 0.319±0.012 0.367±0.004 13.07±0.15 1.15±0.004 28.50±0.98

F6 0.315±0.014 0.361±0.003 12.74±0.21 1.14±0.016 28.90±1.16

F7 0.302±0.021 0.355±0.002 14.92±0.09 1.17±0.014 28.10±0.05

F8 0.304±0.006 0.354±0.005 14.12±0.03 1.16±0.006 27.70±0.47

F9 0.318±0.014 0.373±0.002 14.74±0.02 1.17±0.006 29.20±1.39

F10 0.306±0.012 0.357±0.006 14.28±0.06 1.16±0.005 29.70±1.56

F11 0.315±0.006 0.358±0.007 12.01±0.07 1.13±0.012 29.90±1.23

F12 0.309±0.004 0.356±0.002 13.20±0.14 1.15±0.009 28.10±1.12

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 CHAPTER-5 RESULTS AND DISCUSSION

F13 0.317±0.014 0.371±0.005 14.55±0.09 1.17±0.007 27.80±1.17

F14 0.313±0.015 0.365±0.006 14.24±0.16 1.16±0.005 28.40±1.08

F15 0.308±0.007 0.362±0.005 14.91±0.08 1.17±0.008 29.10±1.13

F16 0.303±0.012 0.344±0.002 11.91±0.04 1.13±0.012 28.50±0.08

F17 0.318±0.003 0.374±0.003 14.97±0.18 1.17±0.006 27.70±1.31

F18 0.315±0.008 0.363±0.004 13.33±0.11 1.15±0.003 29.40±1.19

Note: All values are expressed as mean ± SD. n=3.

Table No.14: Post-compression evaluations of Montelukast Sodium tablet

Formulation Wt. Hardness Thickness Friability Drug Disintegration

Batch variation (kg/ cm2) (mm) (%) Content time
(mg) n=10 (%) (Seconds)

F1 179.4±0.07 3.0±0.20 3.0±0.03 0.33±0.02 98.0±1.02 21±0.04

F2 180.0±1.20 3.0±0.30 3.0±0.02 0.35±0.03 95.0±1.03 14±0.08

F3 179.6±0.30 3.5±0.20 3.4±0.11 0.31±0.02 97.0±1.05 09±0.20

F4 179.2±0.09 3.5±0.18 3.4±0.20 0.31±0.16 97.0±1.05 30±0.05

F5 180.5±0.06 3.5±0.12 3.4±0.08 0.32±0.12 98.0±1.10 36±0.05

F6 181.5±0.08 3.5±0.20 3.4±0.15 0.33±0.11 100±1.02 31±0.10

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 CHAPTER-5 RESULTS AND DISCUSSION

F7 179.3±2.00 3.6±0.17 3.2±0.30 0.34±0.17 96.0±1.04 18±1.02

F8 181.0±1.20 3.6±0.40 3.2±0.60 0.35±1.02 95.0±0.06 17±1.04

F9 179.8±1.00 3.6±0.13 3.2±1.08 0.35±0.09 91.0±0.08 22±0.20

F10 181.1±0.60 3.2±1.20 3.8±0.70 0.34±0.10 93.6±1.04 18±1.06

F11 180.7±1.04 3.0±1.04 3.5±0.09 0.32±0.16 92.0±0.05 13±1.02

F12 178.8±0.30 3.5±0.80 3.5±0.16 0.32±0.03 96.8.±0.10 16±0.06

F13 179.4±0.50 3.5±0.50 3.5±0.40 0.31±0.08 96.0±0.06 40±0.12

F14 180.4±1.02 3.5±0.18 3.6±0.40 0.34±0.11 96.2±1.06 25±1.05

F15 178.6±1.00 3.5±1.15 3.6±0.05 0.32±0.05 95.3±1.02 19±0.16

F16 180.0±0.06 3.5±0.12 3.6±0.15 0.31±0.14 92.2±0.08 21±0.09

F17 179.3±0.07 3.5±1.13 3.6±0.65 0.35±0.17 106±0.09 39±0.10

F18 179.8±0.30 3.5±0.50 3.6±0.15 0.33±0.07 102±1.02 32±1.02

Note: All values are expressed as mean ± SD. n=3

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CHAPTER-5 RESULTS AND DISCUSSION

Pre-compressional evaluation parameters:

Results of the pre-compressional parameters performed on the powder blend for tablets

formulations F1 to F18 are reported in the table no.11. The angle of repose for all the

formulations (F1 – F18) was found to be within the range of 27.30 ± 1.13 to 29.90 ± 1.23,

showing good flow characteristics. Hausner’s ratio was found to be in the range of 1.12 ±

0.003 to 1.17 ± 0.006 and compressibility index was found to be in the range of 11.40 ±

0.14to 14.97 ± 0.18, indicating good flow ability of the tablet formulations.

Post-compression parameters

 Shape and appearance:

White colour, round flat uncoated tablets having one side breakline.

 Weight Variation:

Prepared tablets of all formulations were evaluated for weight variation and standard

deviations from the average weight are reported in table no.12. The average weights of all

the formulations (F1 to F18) were within the range of 179.2 + 0.09 to 181.5 + 0.08. All

the tablets passed the weight variation test, i.e., the average percentage weight variation

was found to be within the prescribed pharmacopoeia limits of ±7.5%.

 Tablet Thickness and Hardness:

The thickness of the tablets from batch F1 to F18 was found to be between 3.0 ± 0.03 to

3.8 ± 0.70 mm and hardness was found to be within the range of 3.0 ± 0.20 to 3.6 ± 0.50

Kg/cm2 as reported in table no.12. The low standard deviation values indicate that the

thicknesses as well as hardness of all the formulations were almost uniform and also the

tablets possess good mechanical strength with sufficient hardness.

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CHAPTER-5 RESULTS AND DISCUSSION

 Friability:

The friability of the formulations (F1 to F18) was found to be between 0.31±0.02% to

0.35±1.02% as reported in table no.12. The obtained results were found to be within the

range (<1%) in all the formulations indicating tablets possess good mechanical strength.

 Drug Content Uniformity:

The Percentage of drug content for F1 to F18 was found to be in the range of 91.0 ±

0.05% to 106.0 ± 0.09 % as shown in table no.12. The results were within the limit (not

< 90% and not > 110%) as specified in Indian pharmacopeia.

 Disintegration Time:

The disintegration time for dispersible tablets F1 to F18 is shown in table no.12. The in-

vitro disintegration time was found to be very less for F3 formulation that is 09 + 0.20

seconds. As the concentration of super disintegrants increases, there is decrease in the

disintegration time.

 In-Vitro Dissolution Studies:

The cumulative percentage drug released from each tablet formulation was studied at

different time intervals. The dissolution profile for formulation F1 to F18 is shown in

table no.21. and graph no.10. Formulation F9 shown better dissolution profile when

compared to remaining formulations.

 Drug Release Kinetics:

The mechanism of drug release from formulation F9 were characterized by zero order

kinetics, first order kinetics, Higuchi’s kinetics, Korsmeyer-Peppas model plots as ore shown

graph 10. It was observed that the high correlation coefficient (R2) was found to be 1. first

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CHAPTER-5 RESULTS AND DISCUSSION

order kinetics, which indicates the drug release rate of fast dissolving tablets would be

dependent of its concentration.

 Stability Studies:

From the stability studies, it was clear that the formulation were physically and

chemically stable for 90 days. And there was no significant change in the physical

parameters, drug content and in-vito dissolution release profiles.

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