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Chapter 5: Experimental Analysis

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 Page 37 

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 mg7.  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

  Maximum weight Variation = × 100

= + 1.01 % w/w

  Maximum weight Variation = × 100

= 0.82 % w/w

329.5 326.19

326.19

329.19

323.5 326.19

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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

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

Dissolution = × × 325 ×

= 242.75 mg or 97.09 %

Friability =

 

0.347 251.1 99.8

0.358 325.2 100

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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

Dissolution = × × 325 ×

= 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

Dissolution = × × 325 ×

= 238.88 mg or 95.55 %

0.357 251.1 99.8

0.358 325.8 100

0.342 251.1 99.8

0.358 325.7 100

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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

Dissolution = × × 325 ×

= 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

0.342 251.1 99.8

0.358 325.1 100

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STD solution preparation

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 :

2850626 285.6 99.8

Test Area STD Weight 1 100 100 Potency

X X X X X X Avg. Weight

STD Area 100 50 Test Weight 1 100

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Assay = × × 325 ×

= 245.53 mg /tablet or 98.21 %

3301042 325.8 100