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Chapter 5: Experimental Analysis

5. EXPERIMENTAL ANALYSIS
5.1 WEIGHT VARIATION
Weight of 20 Tablets = 6.5238 gm

Weight of each tablet

1. 325.5 mg 11. 326.7 mg


2. 327.3 mg 12. 324.5 mg
3. 323.5 mg (Min. weight) 13. 328.1 mg
4. 326.4 mg 14. 324.6 mg
5. 328.1 mg 15. 327.3 mg
6. 325.1 mg 16. 324.7 mg
7. 329.5 mg (Max. weight) 17. 326.6 mg
8. 328.3 mg 18. 325.1 mg
9. 325.6 mg 19. 324.9 mg
10. 325.8 mg 20. 325.3 mg

Average weight 0f 20 Tablets = 326.19 mg

329.5 – 326.19
 Maximum weight Variation = × 100
326.19

= + 1.01 % w/w

323.5 – 326.19
 Maximum weight Variation = × 100
329.19

= – 0.82 % w/w

Analysis of β-Lactam Anti-B iotics (Inhibitors of cell walls Synthesis)


& It’s Raw Materials As Penicillin V
Page 37
Chapter 5: Experimental Analysis

5.2 ANALYSIS FRIABILITY TEST :- (NMT 1.0 %)


Weight of 20 tablet (w1) = 6.5643 gm

Weight of 20 tablet after round (w2) = 6.4386 gm

6.5643 - 6.4386
Friability =
6.5643

= 0.019 % w/w

5.3 ANALYSIS DISSOLUTION TEST :- (NLT 75 %)

Claim of Tablet = 250 mg


I. Dissolution Ist tablet
Weight of (sample) tablet = 325.2 mg weight of STD = 251.1 mg

Reading of Tablet =0.347 Reading of STD = 0.358

0.347 251.1 99.8


Dissolution = × × 325 ×
0.358 325.2 100

= 242.75 mg or 97.09 %

Analysis of β-Lactam Anti-B iotics (Inhibitors of cell walls Synthesis)


& It’s Raw Materials As Penicillin V
Page 38
Chapter 5: Experimental Analysis

II. Dissolution IInd tablet


Weight of (sample) tablet = 325.8 mg weight of STD = 251.1 mg

Reading of Tablet = 0.357 Reading of STD = 0.358

0.357 251.1 99.8


Dissolution = × × 325 ×
0.358 325.8 100

= 249.28 mg or 99.71 %

III. Dissolution IIIrd tablet


Weight of (sample) tablet = 325.7 mg weight of STD = 251.1 mg

Reading of Tablet = 0.342 Reading of STD = 0.358

0.342 251.1 99.8


Dissolution = × × 325 ×
0.358 325.7 100

= 238.88 mg or 95.55 %

Analysis of β-Lactam Anti-B iotics (Inhibitors of cell walls Synthesis)


& It’s Raw Materials As Penicillin V
Page 39
Chapter 5: Experimental Analysis

IV. Dissolution IVth table


Weight of (sample) tablet = 325.1 mg weight of STD = 251.1 mg

Reading of Tablet = 0.342 Reading of STD = 0.358

0.342 251.1 99.8


Dissolution = × × 325 ×
0.358 325.1 100

= 239.32 mg or 95.73 %

5.4 DISINTEGRATION TIME :- (NMT 15 minutes)


Disintegration = 5.3 minutes

5.5 HARDNESS :- (NLT 3.0 kg/cm2)


Hardness = 6.5 kg/cm2

5.6 ASSAY :- (92.5% to 107.5%)

Area of STD (Phenoxymethylpenicillin Potassium) = 3301042

Area of Sample = 2850626

Weight of Sample = 325.8mg

Weight of STD (Phenoxymethylpenicillin Potassium) = 285.6 mg

Average weight = 325 mg

Drug label claim = 250 mg/tablet

STD solution preparation


Analysis of β-Lactam Anti-B iotics (Inhibitors of cell walls Synthesis)
& It’s Raw Materials As Penicillin V
Page 40
Chapter 5: Experimental Analysis

125 mg (Phenoxymethylpenicillin Potassium) 100 ml in diluents

(25 ppm) Make up 50 ml with diluents 1 ml

Test solution preparation

250 mg (Tablet sample) 100 ml in diluents

(25 ppm) Make up 100 ml with diluents 1 ml

Assay :

Test Area STD Weight 1 100 100 Potency

X X X X X X Avg. Weight

STD Area 100 50 Test Weight 1 100

2850626 285.6 99.8


Assay = 99.8 × × 325 ×
3301042 325.8 100
Analysis of β-Lactam Anti-B iotics (Inhibitors of cell walls Synthesis)
& It’s Raw Materials As Penicillin V
Page 41
Chapter 5: Experimental Analysis

= 245.53 mg /tablet or 98.21 %

Analysis of β-Lactam Anti-B iotics (Inhibitors of cell walls Synthesis)


& It’s Raw Materials As Penicillin V
Page 42

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