Abstract
An automated high-performance liquid chromatography (HPLC) assay for ethinyl estradiol and norgestrel or levonorgestrel in oral contraceptive tablets was developed. Tablets were prepared for on-line injection using a solid sampler and segmented continuous flow techniques. The active components were separated from tablet excipients, impurities, and degradation products on reversed-phase C8 and C18 columns by elution with water–acetonitrile–methanol (45:35:15). A UV detector connected in series with a fluorometric detector measured the UV absorbance of levonorgestrel and norgestrel at 240 nm and the fluorescence of ethinyl estradiol at 310 nm (excitation at 210 nm). The method employed computer control of the injection system and solid sampler for synchronization of the chromatographic and segmented flow streams. The method is applicable for content uniformity and stability testing at a rate of eight samples per hour.
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REFERENCES
The United States Pharmacopeia, 21st rev., United States Pharmacopeial Convention, Rockville, Md., 1984, p. 747.
K. R. Bagon and E. W. Hammond. Analyst 103:156–161 (1978).
A. M. Bond, I. D. Heritage, and M. H. Briggs. Anal. Chim. Acta 138:35–45 (1982).
M. A. Johnston. J. Chromatogr. 216:269–278 (1981).
A. J. Khoury and L. J. Cali. J. Pharm. Sci. 56:1485–1489 (1967).
W. F. Beyer. J. Pharm. Sci. 57:1415–1418 (1968).
L. F. Cullen, J. G. Rutgers, P. A. Lucchesi, and G. J. Papariello. J. Pharm. Sci. 57:1857–1864 (1968).
P. M. Short and C. T. Rhodes. Steroids 16:217–224 (1970).
J. C. MacDonald. Am. Lab. 9:69–76 (1977).
J. W. Dolan, J. R. Gant, N. Tanaka, R. W. Giese, and B. L. Karger. J. Chrom. Sci. 16:616–622 (1978).
D. A. Burns, Res. Dev. 4:22–32 (1977).
D. A. Burns, J. L. Fernandez, J. R. Gant, and A. L. Pietrantonio. Am. Lab. 11:79–89 (1979).
The United States Pharmacopeia, 21st rev., Suppl. 1, United States Pharmacopeial Convention, Rockville, Md., 1984, p. 1739.
H. Hofmeister, H. Laurent, and R. Wiechert. Chem. Ber. 106:723–726 (1973).
P. N. Rao. Steroids 23:173–183 (1974).
M. L. Cotter, S. D. Levine, R. Mallory, and C. Shaw. Tetra. Lett. 1939–1942 (1978).
G. A. Hughes and H. Smith. U.S. Patent 3,959,322 (1976).
H. Smith et al. J. Chem. Soc. 4472–4489 (1964).
F. B. Colton, U.S. Patent 2,725,389 (1955).
D. C. DeJongh and J. D. Hribar. Steroids 11:649–666 (1968).
T. J. Foell, R. W. Rees, and H. Smith. U.S. Patent 3,412,112 (1968).
Unpublished results.
The United States Pharmacopeia, 21st rev., United States Pharmacopeial Convention, Rockville, Md., 1984, p. 1230.
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Reif, V.D., Eickhoff, W.M., Jackman, J.K. et al. Automated Stability-Indicating High-Performance Liquid Chromatographic Assay for Ethinyl Estradiol and (Levo)norgestrel Tablets. Pharm Res 4, 54–58 (1987). https://doi.org/10.1023/A:1016434028376
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DOI: https://doi.org/10.1023/A:1016434028376