Test solution: Weigh and powder 20 tablets. Weight sample containing 1mg alprazolam in 100ml of volumetric flask. Add 10ml of mobile phase and sonicate for 10 minutes. Make upto the mark with mobile phase. Filter the solution and inject.
Reference solution: Weigh 25mg of alprazolam reference standard in 25ml volumetric flask. Add 10ml mobile phase and dissolve. Sonicate and make upto the mark. Add 80mg of Propranolol in another 100ml volumetric flask and add 10ml of mobile phase and 1ml of alprazolam reference solution prepared in 25ml volumetric previously. Sonicate the solution and make up with mobile phase upto the mark. Filter and inject.
Chromatographic system:
- Column: A stainless steel column 25cm X4.6mm, C18
- Mobile Phase: Acetonitrile + Buffer (500+500)
Buffer: 6.8gm KH2PO4 in 500ml water. Adjust the pH 3.0 with O.P.A.
- Flow rate: 1.0ml per minute,
- Spectrophotometer set at 254nm,
- Injection volume: 15µl
Inject reference solution. The test is not valid unless the relative standard deviation for replicate injections for each peak is not more than 1.0 percent.
Inject reference solution and the test solution.
Calculate the content of alprazolam and propranolol HCl in the tablet.
Acceptance criteria: 90.0%-110.0%
Formula: (For Alprazolam)
Area of Test WS Wt.(mg) 1 100 Potency
—————–X————–X———X—————–X———–X Average weight
Area of STD 25 100 Test Wt.(mg) 100
Formula: (For Propranolol HCl)
Area of Test WS Wt.(mg) 100 Potency
—————–X——————–X————–X—————–X Average weight
Area of STD 100 Test Wt.(mg) 100
