analysis of ramipril tablets

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analysis of ramipril tablets

TEST PROCEDURE / METHODS

standard testing procedure ramipril tablets

01. Description: Remove 20 tablets from the strip. Place on a white paper and observe visually.
02. Average Weight: Weigh accurately 20 tablets and calculate the average weight.
Average Weight = Weight of 20 tablets / 20

03. Identification

Shake a quantity of the powdered tablets containing 25 mg of Ramipril with 50 ml of acetone, centrifuge for 10 minutes, and filter. Evaporate the filtrate to dryness at 60° for 3 hours. The residue complies with the following test.

Determine by infrared absorption spectrophotometer Compare the spectrum with that obtained with ramipril RS or with the reference spectrum of Ramipril.

04. Dissolution Apparatus No. 1,
Medium. 500 ml of 0.1M hydrochloric acid,
Speed and time. 75rpm and 45 minutes.

Test Solution: Draw sample, filter and carry out the sample

Standard solution. Weigh accurately 50 mg of Ramipril W.S. in a 200 ml volumetric flask. Add 40 ml of 0.1 M hydrochloric acid. heat about to 40°C to dissolve, cool & make the volume with 0.1 M hydrochloric acid..
To 2 ml dilute to 100 ml. with 0.1 M hydrochloric acid. and filter.

Chromatographic system
Use the chromatographic system described in the Assay.

05. Uniformity of Content: Use the chromatographic condition of assay to perform the analysis of Ramipril Uniformity of content.

Standard Preparation of Ramipril: Weigh accurately 50 mg of Ramipril W.S. in a 200 ml volumetric flask. Add 40 ml of 0.1 M hydrochloric acid. heat about to 40°C to dissolve, cool & make the volume with 0.1 M hydrochloric acid.
To 2 ml dilute to 100 ml. with 0.1 M hydrochloric acid. and filter.

Test Preparation: Take ten tablets in different 10 Volumetric Flask of 50 ml add 20 ml 0.1N Hydrochloric acid heat about to 40°C to dissolve, cool & make the volume with 0.1 M hydrochloric acid.
To 5 ml dilute to 100 ml with 0.1N hydrochloric acid.

After saturation of column Separately inject the 50µl of Standard & Test solution. Record the chromatogram and measure the peak response with the reference chromatogram.

Calculation for Ramipril:

Spl. Area Std. Wt. 2 100 50 Potency
———— X———–X ——–X———–X——–X————-X 100
Std Area 200 100 1Tab 10 100

(Calculate the result of labeled amount of Ramipril Eq. to Ramipril, Since the labeled amount of Ramipril.

06. Assay- Ramipril-
2.5 mg Estimation of Ramipril By liquid chromatography

Chromatographic system

– Mobile phase:
Buffer- 1.4 g Sodium perchlorate dissolve in 100 ml water add 0.58 ml phosphoric acid adjust ph 2.5 with trietylamine.

Mobile phase – A mixture of 50V Buffer and 50V Acetonitrile and pH again set with phosphoric acid.

Standard Preparation: – Weigh accurately 50 mg of Ramipril W.S. in a 200 ml volumetric flask. Add 40 ml of 0.1 M hydrochloric acid. heat about to 40°C to dissolve, cool & make the volume with 0.1 M hydrochloric acid..
To 2 ml dilute to 100 ml. with 0.1 M hydrochloric acid. and filter.

Test Preparation: – Weigh & powder of 20 tablets equivalent to 20 mg Ramipril W.S. in a 200 ml volumetric flask. Add 40 ml of 0.1 M hydrochloric acid heat about to 40°C to dissolve, cool & make the volume with 0.1 M hydrochloric acid..
To 5 ml dilute to 100 ml. with 0.1 M hydrochloric acid. and filter.

Calculation: