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Content Inside: 2 Pharmaceutical ADVERTISING SUPPLEMENT THE APPLICATIONNOTEBOOK SEPTEMBER 2006 High Speed Separation of Components of Steroid Drugs using an Extreme High Pressure Liquid Chromatography System (X-LC) Y. Sato, M. Bounoshita, S. Higashidate, and M. Saito JASCO Corporation Betamethasone, a steroid, is administered to reduce tissue inflammation or to suppress the human immune system. 1 The U.S. Pharmacopeia (1) (USP) method requires that HPLC 1.2E+05 analysis of components of a betamethasone drug should have a 1.0E+05 resolution, R, between the analyte and internal standard peaks to be not less than 1.7 and the relative standard deviation for repli- 8.0E+04 V) cate injections to be no greater than 2.0%. Cortisone acetate is also a steroid that has a similar biological 6.0E+04 2 Response ( effect to betamethasone, and is administered to patients who 4.0E+04 have the same symptoms. Similarly, the Japanese Pharmacopoeia (2) method requires that HPLC analysis of components of a cortisone 2.0E+04 drug should have a resolution, R, between the analyte and inter- 0.0E+00 nal standard (propyl paraben) peaks greater than 4; and the rel- 0.50 1.00 1.50 2.00 2.50 Time (min) ative standard deviation for replicate injections to be no more than 1.0%. Figure 1: X-LC chromatogram of a standard mixture of betametha- We examined the utility of an X-PressPak C18S column (2.1 zone, and butyl paraben. Peaks: 1 = betamethazone (0.04 mg/mL), and 2 = butyl paraben (0.057 mg/mL). Chromatographic conditions: mm i.d. x 50 mm L.) packed with 2 m diameter particle size column = X-PressPak C18 (2.1 mm I.D. x 50 mm L); column tempera- packing material for the high speed separation of the above ture = 25 C; mobile phase = acetonitrile/water (40/60); flow rate = 0.7 steroid drugs. The results were examined to determine whether mL/min; detection wavelength = 240 nm; injection volume = 1 L. the performance of the column and chromatography separation meets the USP and JP requirements. 1 Experimental The chromatography system utilized in these experiments was a JASCO X-LC system consisting of a Model 3085PU HPLC 6.0E+04 2 pump, Model 3080DG mobile phase degasser, Model 3067CO column oven, Model 3070UV UV/Vis detector, and Model V) 3059AS auto sampler. 4.0E+04 3 Response ( Results and Discussion Figure 1 outlines the separation of a standard mixture of 2.0E+04 betamethazone (0.04 mg/mL) and butyl paraben (0.057 mg/mL). The X-LC system provides an analysis time 9 times 0.0E+04 shorter than conventional HPLC while the resolution between 1.00 2.00 3.00 4.00 the betamethazone and butyl paraben elutions are 18.8; the Time (min) reproducibility of the peak ratio is 0.44%. These results well exceed the USP requirements for the analysis. Figure 2: X-LC chromatogram of a standard mixture of propyl Figure 2 illustrates the separation of a standard mixture of paraben, butyl paraben, and cortisone acetate. Peaks: 1 = propyl paraben (0.03 mg/mL), 2 = butyl paraben (0.03 mg/mL), and 3 = corti- propyl paraben (0.03 mg/mL), butyl paraben (0.03 mg/mL), sone acetate (0.1 mg/mL). Chromatographic conditions: column = X- and cortisone acetate (0.1 mg/mL). In this example, the X-LC PressPak C18 (2.1 mm I.D. x 50 mm L); column temperature = 25 oC; separation provides an analysis time 4 times less than conven- mobile phase = acetonitrile/water (35/65); flow rate = 0.7 mL/min; tional HPLC while the resolution between the propyl paraben detection wavelength = 254 nm; injection volume = 1 L. and cortisone acetate elutions are 12.2; the reproducibility for the peak ratio as small as 0.44%. These results also exceed the JP requirements for the analysis. Jasco Inc. 8649 Commerce Drive, Easton, MD 21601 References tel. (800) 333-5272 (1) US Pharmacopeia29, 266 (2006) www.jascoinc.com (2) Japanese Pharmacopeia15, 1423 (2006) For More Information Circle #
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