Analysis method of Magaldrate Simethicone and Oxetacaine suspension
1.1 To lay down a procedure for analysis of Magaldrate, Simethicone and Oxetacain Suspension.
2.1 This procedure is applicable to the analysis of Magaldrate, Simethicone and Oxetacain Suspension.in Quality control
3.1 Q.C- Chemist
4.1 Manager-Quality Assurance
5.1 Description: Pour 50 ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution. and by chemical method.
Each 5ml contains:
Magaldrate I.P. eq. to
Anhydrous Magaldrate. 480 mg.
Simethicone I.P. 20mg.
Oxetacain B.P. 10mg.
Method of Megaldrate, Simethicone& Oxetacain:
Estimation of Megaldrate:
To a measured volume containing about 3.0gm of anhydrous megaldrate in a beaker add 100.0ml of 1M hydrochloric acid and stir well until a solution is obtained. Titrate the excess acid with 1M sodium hydroxide to a pH of 3.0, determined potentiometrically. Repeat the procedure without the substances under examination. The difference between titrations represents the amount of hydrochloric acid required.
1 ml of 1M hydrochloric acid is equivalent to 0.0354 g of Megaldrate.
V= Volume (in ml) of sodium hydroxide Solution consumed in titration.
N = Actual normality of sodium hydroxide Solution.
AW= Average weight
Wt. = Weight of Sample.
Estimated of Simethicone:
Transferred an Accurately equivalent 50 mg of Simethicone in 25 ml of dilute hydrochloric acid extract with four 40 ml of petroleum ether (40 to 600c). wash the organic layer with tow 10 ml. portion of water, filter the organic layer through anhydrous sodium Sulphate, collect the filter in pre-dried weighed beaker and dry it on a water Bath and then in air oven at 1050c for one hour.
The difference in weight is the amount of simethicone present in the weight quantity of the sample taken for analysis.
Estimation of Oxetacaine
Buffer: 0.136 gm of potassium di hydrogen orthophosphate buffer was taken diluted to 1000ml with water. adjusted to pH. 3.5 with Orthophosphate.
Mobile phase: Acetonitrile: Buffer
30 : 70
Solvent mixture: Acetonitrile: water
50 : 50
Standard preparation: Weight accurately about 20mg Oxetacaine. Diluted to 100 ml volumetric flask with solvent mixture.
Sample preparation: Taken Accurately equivalent to 20 mg of sample weight. Diluted to 100 ml volumetric flask with solvent mixture.
Flow rate – 1.0 ml /mint.
Column -c18 (150 x4.6) 5µm
Injection volume – 20µl
Temperature – 250c
Retention time -About 2.75 mint.
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|1.0||STP||Standard Testing Procedure|
7.0 ATTACHMENTS (ANNEXES)
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