Analysis method of mefenamic acid and paracetamol suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Mefenamic Acid and Paracetamol.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Mefenamic Acid &Paracetamol in quality control
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE
5.1 Description: Pour 50ml 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 Identification:
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 obtained with the reference solution and by chemical method.
5.5 ASSAY:
Each 5 ml contains
Mefenamic Acid I.P. 50 mg.
Paracetamol I.P. 125 mg.
Estimation of Mefenamic Acid:
By Titration:
Take sample 250 mg of Mefenamic acid in a conical flask & suspend in 50ml water and shake for 5 minutes than filter through G3 glass sintered funnel, discard the filtrate. Wash the residue with water, rejecting the filtrate. Dissolve the residue in previously neutralized methanol 50ml (by using phenol red indicator) and titrate with 0.1 N sodium hydroxide. Each ml of 0.N sodium hydroxide is eq. to 24.13 mg of Mefenamic acid.
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.
Estimation of paracetamol:
Method of Paracetamol:
BY HPLC
BUFFER: 2.72 gm. potassium dihydrogen phosphate. 1000 ml water. adjust to ph. 7.1 with Sodium hydroxide.
Mobile phase: BUFFER: METHANOL
20 : 80
Standard preparation: Weight accurately about 250 mg std wt. of Paracetamol and diluted to 100 ml mobile phase.
Test preparation: Weight accurately equivalent 250 mg paracetamol and Dilute to100 ml of mobile phase.
Wavelength-275 nm
Flow rate 1.0 ml /mint.
Injection volume- 20 micro liter.
Column- C18 250cm x 4.6 mm (5 micron).
6.0 ABREVIATIONS
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | STP | Standard Testing Procedure |
| 2.0 | QA | Quality assurance |
| 3.0 | STD | Standard |
| 4.0 | SPL | Sample |
| 5.0 | I.P. | Indian Pharmacopeia |
| 6.0 | NM | Nano meter |
7.0 ATTACHMENTS (ANNEXES)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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