162.testing Method of Wemet 50-500mg Tablet

WENOVO PHARMACEUTICALS Page Number 1 of 9
Plot No31,32 Punjab Small Industrial Estate Taxila,Pakistan.

Document Number WNP/QC-SAP-162
STANDARD ANALYTICAL PROCEDURE OF Revision Number 001
WEMET 50/500mg TABLET Effective Date August- 2023
Reg.No : 098238 Specification: Innovator’s Specs
Label claim Each film coated tablet contains:
Metformin hydrochloride …………….500mg
Vildagliptin……….……………………50mg
Blend/Final Mix:
Specifications
S# Tests
1 Description White color granular powder, free from visible contamination.
2 Identification Metformin HCl And Vildagliptin must be identified
3 Moisture Content NMT 3.0%
4 Assay (Metformin HCl And Vildagliptin) 90.0%-----110.0%
CORE TABLETS:
S# Tests Specifications
White color, oblong shaped core tablets, one side is scored with bisects line and other
1 Physical Appearance
side is plain
2 Identification Metformin HCl And Vildagliptin must be identified
700mg/tab + 5%
3 Average Weight
4 Weight variation Meets the requirements , <905>

5
Disintegration Time NMT 15 minute
NLT 5.0Kgf
6 Hardness
NMT 1.0%
7 Friability
50/500mg/Tablet
8 Assay (Metformin HCl And Vildagliptin)
(90.0%-----110.0%)
COATED TABLETS:
S# Tests Specifications
Blue color oblong, biconvex film coated tablets, one sides is scored with bisect line
1 Physical Appearance
and other side is plain.
725mg/tab + 5%
2 Average Weight
Meets the requirements,<905>

3 Weight variation
NMT 30 minute
4 Disintegration Time
5 Assay (Metformin HCl And Vildagliptin) (90.0%-----110.0%)
6 Dissolution(Metformin HCl And Vildagliptin) NLT 80.0% of the label claim in 45 minutes
PREPARED BY REVEIWED BY VERIFIED BY APPROVED BY

Q.C Analyst Deputy QCM QCM QAM / Plant Manager
Blend/Final Mix:
1. Description:
White color granular powder, free from visible contamination.
2. Identification:
a) Retention time of sample peak corresponds to the Retention time of standard peak.
3. Moisture Content:
Take 1g of sample on moisture analyzer apparatus at 105ºC for 2-3 minutes and note moisture content of
TOP, MIDDLE and BOTTOM sample.
Acceptance Criteria: NMT 3.0%.
4. Assay:
NLT 90.0% and NMT 110.0% of the labeled amount of Metformin HCl And Vildagliptin.
Mobile phase:
Acetonitrile: Phosphate Buffer: Water (65:20:15)
Buffer
6.75 g/L of Potassium Dihydrogen Phosphate in water. Adjust with 1 M Sodium Hydroxide to a pH of
6.0(±0.01).
Diluent:
Mobile Phase.
Chromatographic Conditions:
 Mode : LC
 Detector : UV 239nm for Metformin HCl, UV 213nm for Vildagliptin
 Analytical Column : 4.6mm x 25-cm, 5µm packing L1(C18)
 Temperature : 25 °C
 Flow rate : 1ml / min
 Inject Volume : 10µL
System suitability
Tailing factor:
NMT 2.0 System suitability solution
Relative standard deviation:
NMT 2.0% Standard solution
Analysis:
Standard solution:
0.008 mg/mL of Vildagliptin and 0.08mg/ml Metformin HCl prepared as follows. Accurately weighed
10mg Vildagliptin working standard and 100mg of Metformin HCl working standard to a 100ml
volumetric flask, add Mobile phase to about 60% of the final volume and sonicate for about 5 min to
dissolve. Make up the volume with mobile phase.
Pipette 2ml from the stock solution in 25ml volumetric flask. Pass through a suitable filter of 0.45- µm
pore size.
Sample solution:
140mg powder weight(equivalent to 10mg Vildagliptin and 100mg Metformin HCl) powder to a 100ml
volumetric flask. Add Mobile Phase to about 60% of the final volume, shake mechanically for about 60
min, and make up the volume with mobile phase.
pore size.
% Results:
Calculate the percentage of Metformin Hydrochloride(C4H11N5,HCl).in the portion of Tablets taken:
Result = (rU/rS) × 100
rU= peak response of metformin hydrochloride from the Sample solution
rS= peak response of metformin hydrochloride from the Standard solution.
Calculate the percentage of Vildagliptin(C17H25N3O2)in the portion of Tablets taken:

rU= peak response of Vildagliptin from the Sample solution
rS= peak response of Vildagliptin from the Standard solution.
CORE TABLETS:
1. Physical Appearance:
White color, oblong shaped core tablets, one side is scored with bisects line and other side is plain
2. Identification:
Retention time of sample peak corresponds to the Retention time of standard peak.
3. Average Weight:
Weigh 20 Tablets individually and calculate Average weight mg/Tab.
4. Disintegration Time:
Take 6 tablets for disintegration test. After attaining the required temperature put the sample tablets, one
in each of six tubes of basket assembly and place discs in each tube. Start the apparatus.
Note down the time when no residue remains on the wire mesh. The disintegration time is considered as
the time when the last tablet has disintegrated.
5. Hardness:
Take NLT 10 tablets for recording hardness of Tablets, Calculate average of readings in kg/f.
6. Friability:
Weigh 20 tablets sample and put in Friability chamber and start rotating after completion of rotating
weigh sample and observe that the sample is free from cracked, cleaved or broking. Calculate the %
friability using formula:
% Friability= (F2 - F1) X 100

(F1)
Where is,
F1 = weight of sample before rotation.
F2 = weight of sample after rotation.
7. Assay:
Mobile phase:
Buffer
6.0(±0.01).
Diluent:
Mobile Phase.
 Mode : LC
System suitability
Tailing factor:

Standard solution:
pore size.
Sample solution:
0.008 mg/mL of Vildagliptin and 0.08mg/ml Metformin HCl prepared as follows. Crush the 10 tablets.
Accurately weighed 140mg powder weight(equivalent to 10mg Vildagliptin and 100mg Metformin HCl)
powder to a 100ml volumetric flask. Add Mobile Phase to about 60% of the final volume, shake
mechanically for about 60 min, and make up the volume with mobile phase.
pore size.
% Results:

COATED TABLETS:
1. Physical Appearance:
Blue color oblong, biconvex film coated tablets, one sides is scored with bisect line and other side is
plain.
2. Average Weight:
Weigh 20 Tablets and calculate Average weight mg/Tab.

3. Disintegration Time:
Take 6 tablets for disintegration test (one in each basket) after attaining the required temperature, put the
sample tablets, one in each of six tubes of basket assembly and place discs in each tube. Start the
apparatus.
Note down the time when no residue remains on the wire mesh. The disintegration time is considered as
the time when the last tablet has disintegrated.
Medium temperature should be 37± 1°C.
4. Assay:
Mobile phase:
Buffer
6.0(±0.01).
Diluent:
Mobile Phase.
 Mode : LC
System suitability
Tailing factor:
Analysis:
Standard solution:

pore size.
Sample solution:
0.008 mg/mL of Vildagliptin and 0.08mg/ml Metformin HCl prepared as follows. Crush the 10 tablets.
Accurately weighed 145mg powder weight(equivalent to 10mg Vildagliptin and 100mg Metformin HCl)
powder to a 100ml volumetric flask. Add Mobile Phase to about 60% of the final volume, shake
mechanically for about 60 min, and make up the volume with mobile phase.
pore size.
% Results:

5.Dissolution:
Dissolution Parameters:
o Medium : 0.01N HCl
o Apparatus : II (paddle method)
o Rpm : 100 rpm
o Time : 45 min
o Volume : 900 mL
o Temperature : 37±0.5°C
Medium preparation:
Take 0.85mL concentrated HCl in 1000mL water.
Mobile phase:
Buffer
6.0(±0.01).
Diluent:
Mobile Phase.
 Mode : LC
System suitability
Tailing factor:
Analysis:
Standard solution:
50.0mg Vildagliptin working standard and 100.0mg of Metformin HCl working standard (equivalent to
50mg Vildagliptin and 100mg Metformin HCl) to a 100ml volumetric flask, add Mobile phase to about
60% of the final volume and sonicate for about 5 min to dissolve. Pipette 2ml from the stock solution in
20ml volumetric flask. Make up the volume with mobile phase. Pass through a suitable filter of 0.45- µm
pore size.
Sample solution:
After 45 min, pass a portion of the sample solution under test through a suitable filter of 0.45-µm pore
size.
% Results:
Result = (rU/rS) × CS × V × 1/L×100

rU= peak response of Metformin hydrochloride from the Sample solution

rS= peak response of Metformin hydrochloride from the Standard solution
CS= concentration of Metformin HCl in the Standard solution (mg/mL)
V= Volume of Medium i.e., 900ml
L=Label claim of Metformin HCl in the Tablet.

Result = (rU/rS) × CS × V × 1/L×100
rU= peak response of Metformin hydrochloride from the Sample solution
rS= peak response of Metformin hydrochloride from the Standard solution
CS= concentration of Vildagliptin in the Standard solution (mg/mL)
V= Volume of Medium i.e., 900ml
L=Label claim of Vildagliptin in the Tablet.
Tolerances:
NLT 80% of the labeled amount Vildagliptin, Metformin hydrochloride is dissolved.


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WENOVO PHARMACEUTICALS Page Number 1 of 9

Plot No31,32 Punjab Small Industrial Estate Taxila,Pakistan.

4 Weight variation Meets the requirements , <905>

Meets the requirements,<905>

5 Assay (Metformin HCl And Vildagliptin) (90.0%-----110.0%)

PREPARED BY REVEIWED BY VERIFIED BY APPROVED BY

Calculate the percentage of Vildagliptin(C17H25N3O2)in the portion of Tablets taken:

% Friability= (F2 - F1) X 100

PREPARED BY REVEIWED BY VERIFIED BY APPROVED BY

Calculate the percentage of Vildagliptin(C17H25N3O2)in the portion of Tablets taken:

Weigh 20 Tablets and calculate Average weight mg/Tab.

PREPARED BY REVEIWED BY VERIFIED BY APPROVED BY

Calculate the percentage of Vildagliptin(C17H25N3O2)in the portion of Tablets taken:

PREPARED BY REVEIWED BY VERIFIED BY APPROVED BY

rU= peak response of Metformin hydrochloride from the Sample solution

Calculate the percentage of Vildagliptin(C17H25N3O2)in the portion of Tablets taken:

PREPARED BY REVEIWED BY VERIFIED BY APPROVED BY

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