Development and validation of a liquid chromatographic method for the determination of the related substances of ramipril in Altace capsules

2000 ◽  
Vol 23 (4) ◽  
pp. 637-651 ◽  
Author(s):  
Barry L Hogan ◽  
Mark Williams ◽  
Anna Idiculla ◽  
Tarik Veysoglu ◽  
Ernest Parente
2009 ◽  
Vol 92 (3) ◽  
pp. 846-854 ◽  
Author(s):  
Phyllis Wilson

Abstract Progesterone and estrogens are hormones produced in the human body that are essential for regulating many vital functions. The three major estrogens produced by women are estriol, estradiol, and estrone. Progesterone is a naturally occurring hormone in both men and women. Pharmaceuticals containing estrogens alone or estrogens in combination with progesterone are commonly used in therapy. Patients requiring unique combinations of the drugs rely on pharmacies to compound the ingredients. In order to assess the potency of drugs containing combinations of estrogens and progesterone, a method was developed to determine all four ingredients simultaneously. The liquid chromatographic method utilized a Bondapak C18 column with an isocratic mobile phase of acetonitrilewater (50 + 50, v/v) at a flow rate of 1.0 mL/min and temperature of 30C. Under these conditions, the order of elution was estriol, estradiol, and estrone, followed by progesterone. UV detection was at 205 nm to monitor elution of the estrogens, then switched to 270 nm to monitor progesterone. The method was applied to the analysis of pharmacy-compounded drugs containing combinations of the hormones. Validation studies demonstrated that the method is accurate and precise.


1991 ◽  
Vol 74 (3) ◽  
pp. 453-455
Author(s):  
Normand Beaulieu ◽  
Terry D Cyr ◽  
Susan J Graham ◽  
Edward G Lovering

Abstract A liquid chromatographic method has been developed for determination of selegiline hydrochloride and related substances in drug raw material and tablet formulations. The method resolves 3 known related compounds from the drug with a limit of quantitation of less than 0.05%. Drug raw material and tablet samples contained ca 0.2 and 0.6% impurities, respectively. These included some related compounds, the identities of which were confirmed by gas chromatography with a Fourier transform Infrared detector.


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