Calibration of Dissolution Apparatus- Chemical (PVT)

Calibration of Dissolution Apparatus- Chemical (PVT)

 

Dissolution Conditions:     

Apparatus	USP Type-1 (Basket) & USP Type-2 (Paddle)
Dissolution Medium	500ml water
Medium Temperature	37°C ± 2°C
Time	30 Minutes
RPM	50 RPM
Wavelength	242nm

 

Reference Standard Details:

 

Sr. No.	Name of Reference Standard	Batch No./Lot No.	Reference No.	Validity
1.	Prednisone standard
2.	Prednisone tablets 10 mg

 

Standard Preparation:

Weigh accurately about ________mg of Prednisone RS in ______ ml volumetric flask, add about _____

ml of absolute ethanol, sonicate to dissolve and dilute up to the mark with water. Pipette out _______ ml of above diluted solution in ______ ml volumetric flask and dilute up to mark with water. Take absorbance at 242nm

Observations:

USP Type-1 (Basket)				USP Type-2 (Paddle)
Sr. No.	Absorbance of sample	% Drug Dissolved		Sr. No	Absorbance of sample	% Drug Dissolved
1.				1.
2.				2.
3.				3.
4.				4.
5.				5.
6.				6.
7.				7.
8.				8.
9.				9.
10.				10.
11.				11.
12				12
GM				GM
%CV				%CV

Acceptance criteria :   The geometric mean (GM) and percent coefficient of variation (%CV) should be within the limit as per current certificate lot .

 

1) For Paddle

1. a) GM=____________ b) % CV=___________

 

2) For Basket

1. a) GM=____________ b) % CV=___________

 

% Dissolution = Spl Abs x Std Wt.x  _5_ x 500  x  Purity of Std x 100

Std Abs        50           50      1                 100          10

 

 

Remark: The results Complies/Does not complies as per acceptance criteria.

 

 

 

Performed By: ________________    Checked By: _____________

 Date: __________                             Date: ___________________