CHEMICAL TEST FOR TABLETS

1. DISSOLUTION TEST
Dissolution is a process in which a solid substance solubilizes in a given solvent,
thus there is mass transfer from the solid surface to the liquid phase.
Dissolution rate is defined as the amount of solid substance that goes into solution
per unit time under standard conditions of temperature, pH and solvent
composition.

Dissolution test determines the amount of active ingredient(s) released from a

solid oral dosage form, such as a tablet or a capsule, using a known volume of
dissolution medium within a predetermined length of time.
In vivo studies cannot be done for each batch of tablets manufactured so in vitro dissolution tests have been developed as indirect measurement of drug
availability.

Dissolution behaviour of drugs has a significant effect on their pharmacological

activity. In fact, a direct relationship between in vitro dissolution rate of many
drugs and their bioavailability has been demonstrated and is generally referred to
as in vitro-in vivo correlation, IVIVC
Dissolution Apparatus
A variety of designs of apparatus for dissolution testing have been proposed and
tested, varying from simple beaker with stirrer to complex systems. The choice of
the apparatus to be used depends largely on the physicochemical properties of the
dosage form

Apparatus #

USP

BP

apparatus 1

Rotating basket

Rotating basket

apparatus 2

Paddle

Paddle

apparatus 3

Flow-through cell

apparatus 4

Reciprocating cylinder

Flow-through
cell

apparatus 5

Paddle over disk

apparatus 6

Cylinder

apparatus 7

Reciprocating holder

Parts

Vessel
Basket
Paddle
Water bath
Motor
10 Mesh

Conditions

Dissolution Medium (Generally 500, 900 or 1,000 ml

Simulate gastric fluid (SGF)
Simulate intestinal fluid (SIF)
Temperature: 370.5C
Agitation
Basket method
50-100 rpm
Paddle method
50-75 rpm

Procedure

Media is measured and transferred into dissolution flask.

Temperature should be 370.5
1 Tablet is placed at bottom.
Paddle is rotated at 50 rpm.
10ml of sample is withdrawn at o min and transferred into test tube
approximately labelled. Immediately replace with 10ml of fresh media.
Similarly samples are collected at 5, 10, 15, 20, 25 & 30 min interval. A 10 ml of
fresh dissolution medium is placed in flask when ever sample is withdrawn.
All samples are filtered using Whatmann filter paper.
Absorbance is measured.
Amount of drug dissolved is calculated using standard plot/standard curve.
Data is processed.
Graph is plotted by taking cumulative % drug dissolved on Y-axis and time on Xaxis.
Repeat the test of 5 more tablets.

Time (min)

Abs

Dilution

%Release

0.275

10

16.1200

10

0.397

10

26.4489

15

0.49

10

36.0839

30

0.754

10

57.7117

45

0.91

10

74.9043

60

0.959

10

86.6759

Limits

All the six tablets should dissolve as mentioned in the official monograph
If 1-2 tablets fail, repeat the test on additional 6 tablets

Not less than 10 out of 12 should meet the requirements.

2. Content Uniformity Test For Tablets

If the drug is potent (USP specifies 50 mg of the active ingredient or less), the excipients
form the greater part of the tablet weight and the correlation between the tablet weight
and amount of the active ingredient can be poor, in this case Content uniformity must be
performed .
The content uniformity test is used to ensure that every tablet contains the amount
of drug substance intended with little variation among tablets within a batch. CUT
is Based on assay of individual contents of active ingredient
The content uniformity test has been included in the monographs of all coated and
uncoated tablets.
USP defines content uniformity test for
Tablets containing 50 mg or less of drug substance OR
Tablets that contain < 10% w/w of active ingredient.
Procedure
Select 30 tablets randomly from the batch
At least 10 of them are assayed individually while the 20 tablets are kept aside.
Individul unit s crushed and assayed using spectrophotometer or HPLC.
The result will be calculated as ;
% assay of unit dose = ABSORBANCE OF SAMPLE
Absorbance of standard

X 100

Results / Limits
Out of 10 tablets 9 tablets must not contain less than 85 % and not more than 115
% of the labeled drug content ( 15% )
If one tablet falls out of 15% but within 25 % of the labeled drug content , then
repeat the assay on remaining 20 tablets individually.
Out of 30 tablets , 27 tablets must be within 85-115 % ( 15 %) while 3 tablets can
be within 75-125 % ( 25 % ).
3)ASSAY OF ACTIVE INGREDIENTS

Assay of active ingredients is carried out to ensure a constant dose of drug in a batch. It is
qualitative as well as quantitative test.
Procedure
Weigh 20 tablets
Grind in pestel and mortar
Take weight of powder equal to one tablet.
Analyze by the method prescribed in monograph.
Results obtained are expressed as %age of active ingredient as in single unit
% assay = Absorbance of sample X 100
Absorbance of Std
LIMITS
Compare the result with the standard.
The result should be within specified limits usually 10 % (90-110%).