Determine by liquid chromatography.
Test solution: Weigh and powder 20 tablets. Weigh a quantity of powdered tablets containing
25mg of ramipril, disperse in 100.0 ml of 0.1 M HCl and centrifuge. Dilute 1.0ml of the resulting solution to 100.0 ml with 0.1 M HCl.
Reference solution: A 0.00025 per cent w/v solution of ramipril rs 0.1 m hydrochloric acid.
Chromatographic system:
- A stainless steel column 12.5 cm x 4.6 mm packed with octadecylsilane bonded to
Porous silica (5µm),
- Mobile phase; a mixture of 42 volumes of acetonitrile and 58 volumes of solution containing 1.4 per cent w/v solution of sodium perchlorate and 0.58 per cent w/v solution of orthophosphoric acid adjusted to pH 2.5 with triethylamine, adjust the pH of the mixture to
2.1 with O.P.A.
- flow rate: 1 ml per minute,
- Spectrophotometer set at 210 nm,
- Injection volume: 50 µl.
Inject the reference solution. The test is not valid unless the relative standard deviation for replicate injections is not more than 2.0 per cent.
Inject the reference solution and the solution. Calculate the content of Ramiprl.
Acceptance criteria: 90.0%-110.0%
