This is the experiment lab manual on dissolution study or PCM Marketed brand. Finally, calculate the pencent drug release and Absorbance using Dissolution (LabIndia) Apparatus.

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IN-VITRO DISSOLUTION PROFILE STUDIES OF PARACETAMOL (PCM)
MARKETED TABLET FORMULATION
Experiment Findings · February 2023
DOI: 10.13140/RG.2.2.27508.63366
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2. PHARMACEUTICS EXPERIMENT February 14, 2023
1 | P a g e
DISSOLUTION STUDIES OF PARACETAMOL MARKETED TABLET
Rahul Pal*, Prachi Pandey (M. Pharm) Pharmaceutics
NIMS Institute of Pharmacy, NIMS University Jaipur, Rajasthan India.
Object: To perform the In-Vitro dissolution profile of paracetamol marketed tablet and calculate the
percentage drug release.
‘OR’
To perform the dissolution studies of PCM and calibration curve of drug release or cumulative curve.
‘OR’
To perform In-Vitro dissolution profile of Sustained Release (SR)/Controlled Release (CR) marketed
formulation.
References:
01. Leon Lackman, Leibermann, “The Theory and Practice of Industries Pharmacy” 3rd edition,
pharmaceutical dosage form, Verghese publishing house (2009), page no. 293-345.
02. Bhi, SB, Diash, J. Dhowle SC, “Laboratory manual of biopharmaceutics &
Pharmacokinetics”, Publishing house, re-print (2010), page no. 121-125.
Requirement:
• Chemicals: PCM (Dolo 650 or Paracip 650)/SR/CR Tablet, Phosphate Buffer, pH 6.8, Distilled
water.
• Glassware: Volumetric Flask (1000ml, 100ml & 10ml), Beakers with different volume, Pipette
injection.
• Apparatus: Dissolution Apparatus 2- Paddle, (ElectroLab), UV-Visible spectrophotometer with
matched quartz cells (1cm).
Principle: Dissolution is pharmaceutically defined as the rate of mass transfer from a solid surface into
the dissolution medium or solvent under standardized conditions of liquid/solid interface, temperature and
solvent composition. It is a dynamic property that changes with time and explains the process by which a
homogenous mixture of a solid or a liquid can be obtained in a solvent. In vitro drug dissolution data
generated from dissolution testing experiments can be related to in vivo pharmacokinetic data by means
of in vitro-in vivo correlations (IVIVC).

3. PHARMACEUTICS EXPERIMENT February 14, 2023
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The main objective of developing and evaluating an IVIVC is to establish the dissolution test as a surrogate
for human bioequivalence studies, as stated by the Food and Drug Administration. Analytical data from
drug dissolution testing are sufficient in many cases to establish safety and efficacy of a drug product
without in vivo tests, the dissolution testing which is conducted in dissolution apparatus must be able to
provide accurate and reproductive results. Several dissolution apparatuses exist. “Dissolution testing is
an essential analytical procedure that's required as part of the final release investigation for solid oral
dosage forms.”
The solubility of considering Paracetamol (Half-Life 1.5-2.5 hour) marketed tablets has been very soluble
in the given 0.1N HCl solution with the 89.4.
Sr. No. Solvent (Medium) Solubility ± SD (Microgram/ml) of PCM
01. Distilled water 14.7 ± 0.2
02. 0.1N HCl 89.4 ± 0.1
03. Phosphate Buffer pH 6.8 5.6 ± 0.1
In United States Pharmacopeia (USP), there are four dissolution apparatuses standardized and specified
they are:
1. USP Dissolution Apparatus 1 - Basket (37°C)
2. USP Dissolution Apparatus 2 - Paddle (37°C), USP Dissolution Apparatus 2 is the most widely
used apparatus among these four.
3. USP Dissolution Apparatus 3 - Reciprocating Cylinder (37°C)
4. USP Dissolution Apparatus 4 - Flow-Through Cell (37°C).
Procedure:
Preparation of solutions for Calibration curve:
➢ Stock solution 1: Stock solution of drug (1mg/ml) is prepared by dissolving 100 mg of drug in
100 ml solution of methanol and phosphate buffer pH 6.8 (in 1:3 ratio) in 100 ml volumetric flask
(to get 1000 µg/ml drug solutions) with vigorous shaking and further sonicated for about 10
minutes.

4. PHARMACEUTICS EXPERIMENT February 14, 2023
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➢ Stock solution 2: 10 ml of this (Stock solution 1) is diluted to 100ml with phosphate buffer pH
6.8 to get a stock solution containing 100 µg/ml of drug. The stock solution was filtered through
Whatmann filter paper No. 41.
Dilutions: Take the respective samples (0.2ml, 0.4ml, 0.6ml, 0.8ml, 1ml, 1.2ml, 1.4ml….2.2ml, 2.4ml)
in each test tube, add phosphate buffer pH 6.8 to make total volume of 10 ml to produce (2, 4, 6, 8, 10,
12……..24µg/ml) respectively.
Determination of Absorption Maxima: A UV absorption maximum was determined by scanning
10µg/ml solution of paracetamol in phosphate buffer with pH 6.8, in between 200-400 nm by using UV-
visible spectrophotometer. Further a representative spectrum was drawn of paracetamol in phosphate
buffer pH 6.8.
Preparation of Calibration Curve: The standard solutions for the drug having concentration 2, 4, 6, 8,
10……20 and 24µg/ml was prepared with phosphate buffer pH 6.8 from the stock solution. The
absorbance of solutions of pure paracetamol drug were measured at 243 λ max and a calibration curve
was plotted between absorbance v/s concentration to get the linearity and regression equation which has
shown in (Fig. 2).
Phosphate buffer preparation:
Phosphate buffer: Place 50ml of 0.2 M Potassium di-hydrogen phosphate (KH2PO4) in a 200ml
volumetric flask, add the specified volume of 0.2 M sodium hydroxide NaOH (Shown Table) and then
add distilled water to make up the volume 200ml.
Preparation of 0.2 M Potassium di-hydrogen phosphate solution: Dissolve 27.218g of potassium di-
hydrogen phosphate ((KH2PO4) in sufficient distilled water containing in the 1000ml volumetric flask
and to make up to the volume 1000ml.
Preparation of ‘x’ M sodium hydroxide: Solution of any molarity ‘x’ Molar may be prepared by
dissolving 40*x gm of sodium hydroxide, NaOH in sufficient distilled water containing in the 1000ml
volumetric flask and make up to the volume 1000ml.
Dissolution Apparatus procedure: Before the starting of dissolution apparatus, should set the dissolution
apparatus properly.
1) Switch the heater of the dissolution device on and manage the temperature to reach 370C.

5. PHARMACEUTICS EXPERIMENT February 14, 2023
4 | P a g e
2) Wash the vessel (of dissolution apparatus) using water and surfactant then put 900 ml of
medium (phosphate buffer pH 6.8) in each.
3) Elevate the paddle 25±2 mm from the bottom of the vessel.
4) Operate the paddle on a rotation speed equals to 50 RPM.
5) Add one 500 mg tablet in one vessel which you previously cleaned and at once start timing.
6) At specified time intervals (5, 10, 15, 20, 25, 30, 45 and 60 min) Withdraw 1 ml using the
volumetric pipette from each filtrated sample (filtrate) and put it in 10 ml volumetric flask
(clean and neat), then complete the volume up to 10 ml by the medium (phosphate buffer
at pH=6.8).
7) Replace the same volume into dissolution vessel by another volumetric pipette.
8) Read the absorbance of the diluted sample solutions at λ=243 nm using the buffer as a
blank.
9) Plot a graph between Time intervals on x-axis vs % of drug release on y-axis.
10) Find out the slope, concentration, amount of drug release, percentage of drug release and
report it.
Absorbance of Paracetamol (PCM) at 243nm has been shown in the given below table.
The absorbance of given PCM marketed tablet, as hypothetically following with the research paper.
Calculations: Calculations for calibration curve of pure paracetamol drug.
Sr. No. Concentration Absorbance
01. 1 0.128
02. 2 0.282
03. 4 0.378
04. 6 0.486
05. 8 0.589
06. 10 0.695

6. PHARMACEUTICS EXPERIMENT February 14, 2023
5 | P a g e
PCM Tablet Spectrum drawn below
Fig. 2: Calibration Curve of Paracetamol in mix. solution of phosphate buffer 6.8 and Methanol
(3:1) further diluted with phosphate buffer pH 6.8 at λ max 243 nm.
Table for specified volume of NaOH required preparing buffer solutions:
Sr. No. pH Volume of 0.2M NaOH (ml)
1 5.8 3.6
2 6 5.6
3 6.2 8.1
4 6.4 11.6
5 6.6 16.4
6 6.8 22.4
7 7 29.1
8 7.2 34.7
9 7.4 39.1
y = 0.0587x + 0.1226
R² = 0.9757
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0 5 10 15
Conc. (µg/ml
)
Absorbance
Linear (Absorbance)

7. PHARMACEUTICS EXPERIMENT February 14, 2023
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Table to calculate percentage (%) of Cumulative Drug Release: These readings just a hypothesis
dissolution, for the completion of dissolution calculation.
Sr.
No.
Time Absorbance
(L.mol-
Cm-
)
Concentration
of sample
(μm/ml)
Concentration
of sample
(mg/ml)
Concentration
of 900ml
Amt. of
drug release
% Of
Cumulative
Drug
Release (%CR)
1. 0 0 0 0 0 0 0
2. 5 0.46 5.48 0.0054 49.3 0.39 39.48
3. 10 0.51 6.16 0.0061 55.45 0.44 44.36
4. 15 0.566 7.06 0.0070 63.58 0.51 50.86
5. 20 0.599 7.78 0.0077 68.38 0.55 54.70
6. 25 0.612 7.81 0.0078 70.26 0.56 56.21
7. 30 0.634 8.16 0.0081 73.46 0.59 58.76
Plot graph between Time on x-axis vs % of drug release (CR) on y-axis from above table and calculate
slope.
Slope = Y2-Y1 / X2-X1 y=m* x + c y=absorbance m=slope x=concentration, c=y-intercept
Amount of Drug Release (CR) = Concentration * Volume of Dissolution Medium
1000
% Drug Release (%CR) = Amount of Drug Release * Dilution Factor
Drug Dose
Result: The In-Vitro Dissolution profile of SR/CR/Paracetamol marketed tablets were performed, the %
of drug release was found to be..58.76%..and the calibration curve of PCM has been carefully plotted.
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