Analysis method of Levocetirizine Dihydrochloride syrup
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Levocetirizine Dihydrochloride Syrup.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Levocetirizine Dihydrochloride Syrup quality control laboratory
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 with the reference solution.
5.5 ASSAY:
Each 5.0 ml contains:
Levocetirizine Dihydrochloride I.P. 2.5 mg.
Estimation Levocetirizine Dihydrochloride:
Method of Levocetirizine Dihydrochloride:
By HPLC:
BUFFER: Dissolve 3.85 Ammonium Acetate 1000 ml of distilled water adjust to ph. 5.5 with Glacial Acetic acid.
MOBILE PHASE: BUFFER : METHANOL
20 : 80
Standard preparation: Weight accurately about 50mg std wt. of Levocetirizine Dihydrochloride diluted to 100 ml volumetric flask with mobile phase. Further dilution 5.0 to 50 ml with mobile phase
Sample preparation: Taken 10ml sample diluted to 100 ml volumetric flask with mobile phase.
Chromatographic condition:
Wavelength – 220nm.
Flow rate – 1.2 ml/mint.
Injection volume -50 µl.
Column – C18 125mm x4.6 (5.0 µm.)
Temperature – 250c
Calculation:
6.0 ABBREVIATIONS
| 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 (ANNEXURE)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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