Analysis of Oxcarbazepine Tablets

TEST PROCEDURE / METHODS

01. Description: Remove 20 tablets from the strip. Place on a white paper and observe visually.

02. Identification

In the assay, the principle peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with reference solution.

03. Average Weight Weigh accurately 20 tablets and calculate the average weight.
Average Weight = Weight of 20 tablets/20

04. Uniformity of weight Weigh twenty (20) units, taken individually and record their weights.
Calculate the maximum and the minimum weights recorded. Not
more than two of the individual weights deviate from the average weight
by more than the percentage shown in the table and none deviates by
more than twice that percentage.

AVE. WT. OF TAB PERMISSIBLE DEVIATION
Up to 80.0 mg ± 10 %
More than 80.0 mg. but less than 250 mg. ± 7.5 %
250 mg. or more ± 5.0 %

05 Dissolution Apparatus. No 1, (Paddle)

Buffer- 45 gm sodium lauryl sulphate dissolve in 6 liters water
Standard Preparation
Weigh accurately (84)mg dissolve in 40 ml methanol heat upto 50 C and dilute to 100 ml with methanol.
To 5 ml dilute to 25 ml with Dissolution medium, filter
To 5ml dilute to 25 ml with dissolution medium.

RPM-75 Time 45 min Limit NLT 75%
Procedure
1 tablet in 900 ml in Paddle, after operation filter than
To 5 ml of filtrate and dilute to 25 ml in dissolution medium

Calculation

D. Not less than 75%

6.0 Related Substances Determine by liquid chromatography

Related Sub Note- Use freshly prepared solution-
Te Test solution A. Weigh a quantity of the powdered tablets containing 50 mg of
Oxcarbazepine add 15 ml methanol mix with the aid of ultrasound of 15 minutes and
dilute to 100 ml with methanol. Mix & centrifuge.
Test solution B Dilute 5 ml of solution A to 25 ml with mobile phase.

Re Reference solution (a). Dissolve 25.0 mg Oxcarbazepine RS in methanol with the aid of ultrasound abd dilute to 50 ml with methanol.A 0.05% w/v solution of Oxcarbazepine
RS in the mobile phase .
Reference solution (b). Dilute 5.0 ml of reference solution (a) to 25.0 ml with mobile
phase .
Reference solution C Dilute 1 ml of reference solution A to 100 ml with mobile phase.
Chromatographic system:
Column : a stainless steel column 25 cm × 4.6 mm packed with
octadecylsilane Bonded to porous silica (5 μm), (such as
Intersil C18)
Column temperature: 50° C,
Flow rate : 2.0 ml/min
Wavelength : 215 nm
Injection volume : 20 μl.

Buffer – 6.8 g Potassium dihydrogen phosphate dissolve in 1000 ml water
Mobile phase:- 20V Methanol+14V Acetonitrile & 66 V of buffer+0.1 ml
triethylamine and adjust pH-6.0 with orthophosphoric acid.

Inject reference solution (a) , The test is not valid unless
1. The tailing factor is not more than 2.0
2. Theoretical plates is not less than 2000.

Inject test solution A and reference solution (c) and the test solution run chromatograms about 30 minutes

Not more than 1.0% Any secondary peak
1. Not more than 2.0% All secondary peak
7.0 Assay
By HPLC describe as Related substances

Inject Test solution B and reference solution B

Sequence of Injection