Analysis of Sodium Alendronate Tablets

TEST PROCEDURE / METHODS

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

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

3. 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 %

4. 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.

5 Disintegration Time Place six tablets one each in six tubes of the basket in a suitable disintegration test apparatus. Previously suspend the assembly in water (about 700 ml) maintained at a temperature of 37˚C ± 2˚C and operate the apparatus with disc to each tube. The tablets pass the test, if all the tablets have disintegrate (no residue of the tablet remains on the screen of the apparatus or, if a residue remains, it consists of fragments of insoluble coating of the tablets or is a soft mass with no palpable core) in 15 minutes. If 1 or 2 tablets fail to disintegrate, repeat the test on 12 additional tablets, not less than 16 of the total of 18 tablets tested disintegrate. If the tablets adhere to the disc and the preparation being examined fails to comply, repeat the test omitting the disc.
6 Assay- By Liquid Chromatographic

Column:- A stainless steel column 250 x 4.6 mm packed with
Octyldecylsilane bonded to porous silica (C18, 5μm)

Buffer- 1.47 g Sodium citrate dehydrate + 0.705 gm Disodium hydrogen phosphate dissolve in 100 ml water adjust pH-8.0 with orthophosphoric acid.
Mobile phase- Buffer 70V + Acetonitrile 25V+Methanol 5V.

Flow rate :-1.2 ml per minute,
Wavelength:- 266 nm,
Injection volume: 20 μl.

Diluent– 7.35 g sodium citrate dehydrate dissolve in 250 ml water.
Borate solution- 1.91 gm disodium borate (Borex) dissolve in 100 ml water.
Reagent- 10 mg 9 fluorenylmethylchloroformate.

Standard Preparation
Weight accurately about 92 mg Sodium Alendronate WS dissolve in 30 ml diluent heat upto 40°C , sonicate for 1 minute, cool and dilute to 100 ml with diluents shake & stand for 30 minutes at 37°C.

Test Preparation
Weigh and powder of 20 tablets, weigh a quantity of the powdered tablets containing eq.to 70 mg of Alendronate dissolve 30 ml diluent heat upto 40°C , sonicate for 1 minute, cool and dilute to 100 ml with diluents shake & stand for 30 minutes at 37°C.

Procedure-
To 5 ml standard and test in separate 25 volumetric flask+5 ml borate solution (Already set at 37°C) + 5 ml Reagent keep at 35 to 40°C for at least 30 minutes and dilute to 25 ml with water.
Retention Time for
1. Sodium alendronate about 5 minutes
2. Reagent about 50 minutes

Calculation

Analysis of Sodium Alendronate Tablets

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