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Year 2023, , 456 - 463, 29.09.2023

Bilal Yılmaz , Mevlüt Albayrak , Yücel Kadıoğlu

https://doi.org/10.17776/csj.1303270

Abstract

References

  • [1] Yuan T.F., Le J., Wang S.T., Li Y., An LC/MS/MS Method for Analyzing the Steroid Metabolome with High Accuracy and from Small Serum Samples, J. Lipid Res., 61 (2020) 580-586.
  • [2] De Wilde L., Roels K., Van Renterghem P., Van Eenoo P., Deventer K., Steroid Profiling in Urine of Intact Glucuronidated and Sulfated Steroids Using Liquid Chromatography-Mass Spectrometry, J. Chromatogr. A., 1624 (2020) 461231.
  • [3] Van Renterghem P., Viaene W., Van Gansbeke W., Barrabin J., Iannone M., Polet M., T’Sjoen G., Deventer K., Van Eenoo P., Validation of an Ultra-Sensitive Detection Method for Steroid Esters in Plasma for Doping Analysis Using Positive Chemical Ionization GC-MS/MS., J. Chromatogr. B., 1141 (2020) 122026.
  • [4] Gomez-Gomez A., Miranda J., Feixas G., Arranz Betegon A., Crispi F., Gratacós E., Pozo O.J., Determination of the Steroid Profile in Alternative Matrices by Liquid Chromatography Tandem Mass Spectrometry, J. Steroid Biochem. Mol. Biol., 197 (2020) 105520.
  • [5] Sayeed I., Wali B., Guthrie D.B., Saindane M.T., Natchus M.G., Liotta D.C., Stein D.G., Development of a Novel Progesterone Analog in the Treatment of Traumatic Brain Injury, Neuropharmacology, 145 (2019) 292-298.
  • [6] Struk W.R., Progestogens in Hormonal Replacement Therapy: New Molecules, Risks, and Benefits, Menopause 9 (2002) 6-15.
  • [7] Belchetz PE., Hormonal Treatment of Postmenopausal Women, N. Engl. J. Med., 330 (1994) 1062-1071.
  • [8] Kawaguchi M., Takatsu A., Miniaturized Hollow Fiber Assisted Liquid-Phase Microextraction and Gas Chromatography-Mass Spectrometry for the Measurement of Progesterone in Human Serum, J. Chromatogr. B., 877 (2009) 343-346.
  • [9] Ishibashi M., Takayama H., Nakagawa Y., Harima N., Diethylhydrogensilyl-Cyclic Diethylsilylene Derivatives in Gas Chromatography/Mass Spectrometry of Hydroxylated Steroids. Analysis of Cortisol and 6 Beta-Hydroxycortisol in Human Urine, Chem. Pharm. Bull., 36 (1988) 845-848.
  • [10] Ichimiya H., Egestad B., Nazer H., Baginski E.S., Clayton P.T., Sjövall J., Bile Acids and Bile Alcohols in a Child with Hepatic 3 Beta-Hydroxy-Delta 5-C27-Steroid Dehydrogenase Deficiency: Effects of Chenodeoxycholic Acid Treatment, J. Lipid Research, 32 (1991) 829-841.
  • [11] Setchell K.D., Suchy F.J., Welsh M.B., Zimmer-Nechemias L., Heubi J., Balistreri W.F., Delta 4-3-Oxosteroid 5 Beta-Reductase Deficiency Described in Identical Twins with Neonatal Hepatitis. A New Inborn Error in Bile Acid Synthesis, The J. Clin. Invest., 82 (1988) 2148-2157.
  • [12] Meng L.J., Sjövall J., Method for Combined Analysis of Profiles of Conjugated Progesterone Metabolites and Bile Acids in Serum and Urine of Pregnant Women, J. Chromatogr. B., 688 (1997) 11-26.
  • [13] British Pharmacopoeia, British Pharmacopeia Commission, London, (2000) 2197.
  • [14] Shi Y., Yao J., Liu F., Hu C., Yuan J., Zhang Q., Jin S., Establishment of an HPLC Identification System for Detection of Counterfeit Steroidal Drugs, J. Pharm. Biomed. Anal., 46 (2008) 663-669.
  • [15] De Orsi D., Pellegrini M., Pichini S., Mattioli D., Marchei E., Gagliardi L., High-Performance Liquid Chromatography-Diode Array and Electrospray-Mass Spectrometry Analysis of Non-Allowed Substances in Cosmetic Products for Preventing Hair Loss and Other Hormone-Dependent Skin Diseases, J. Pharm. Biomed. Anal., (2008) 48641-648.
  • [16] Alambiaga-Caravaca A.M., Domenech-Monsell I.M., Sebastián-Morelló M., Miranda M., Balaguer-Fernández C., Calatayud-Pascual A., Rodilla V., López-Castellano A., HPLC-UV Analytical Validation of a Method for Quantification of Progesterone in Ex Vivo Trans-Corneal and Trans-Scleral Diffusion Studies, J. Pharm. Biomed. Anal., 193 (2021) 113749.
  • [17] Sun L., Zhang B., Sun J., The Solubility-Permeability Trade-Off of Progesterone with Cyclodextrins under Physiological Conditions: Experimental Observations and Computer Simulations, J. Pharm. Sci., 107 (2018) 488-494.
  • [18] Maliwal D., Jain P., Jain A., Patidar V., Determination of Progesterone in Capsules by High-Performance Liquid Chromatography and UV-Spectrophotometry, J. Young Pharmacist., (2009) 1371-374.
  • [19] Pucci V., Bugamelli F., Mandrioli R., Luppi B., Raggi M.A., Determination of Progesterone in Commercial Formulations and in Non Conventional Micellar Systems, J. Pharm. Biomed. Anal., 30 (2003) 1549-1559.
  • [20] El-Yazbi F.A., Korany M.A., Abdel-Razzak O., Elsayed M.A., Derivative Spectrophotometric Analysis of Oestradiol Esters, Testosterone and Progesterone in Oily Injections, Anal. Lett., 18 (1985) 2127-2142.
  • [21] The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95 (1996).
  • [22] United States Pharmacopeia, 23th ed., Rockville United States: Pharmacopeial Convention, Inc., (1995).

Determination of Progesterone in Pharmaceutical Preparations by UV, First-order Derivative Spectrophotometry and Gas Chromatography

Year 2023, , 456 - 463, 29.09.2023

Bilal Yılmaz , Mevlüt Albayrak , Yücel Kadıoğlu

https://doi.org/10.17776/csj.1303270

Abstract

The determination of progesterone in pure and capsule form was accomplished in this work using new, simple and quick procedures by UV spectrophotometry, first-order derivative spectrophotometry and gas chromatography. To increase the sensitivity of the suggested methods, it was necessary to optimize the solvent system, the detection wavelength, and the chromatographic conditions. The linear regression equations for the UV spectrophotometry, first-order derivative spectrophotometry and gas chromatography were y=0.0536x+0.0002, y=0.1362x+0.0014, and y=1.8217x-1.239, respectively, as determined by the least square regression approach. Under the chosen experimental conditions, no interference was found. The suggested methods are extremely accurate and precise. When the suggested methods' findings were compared to those of two published reference methods, there was statistically no discernible difference. Therefore, the methods are applicable to the measurement of progesterone in pharmaceutical formulations.

Keywords

Progesterone Spectrophotometry Gas chromatography Validation.

References

  • [1] Yuan T.F., Le J., Wang S.T., Li Y., An LC/MS/MS Method for Analyzing the Steroid Metabolome with High Accuracy and from Small Serum Samples, J. Lipid Res., 61 (2020) 580-586.
  • [2] De Wilde L., Roels K., Van Renterghem P., Van Eenoo P., Deventer K., Steroid Profiling in Urine of Intact Glucuronidated and Sulfated Steroids Using Liquid Chromatography-Mass Spectrometry, J. Chromatogr. A., 1624 (2020) 461231.
  • [3] Van Renterghem P., Viaene W., Van Gansbeke W., Barrabin J., Iannone M., Polet M., T’Sjoen G., Deventer K., Van Eenoo P., Validation of an Ultra-Sensitive Detection Method for Steroid Esters in Plasma for Doping Analysis Using Positive Chemical Ionization GC-MS/MS., J. Chromatogr. B., 1141 (2020) 122026.
  • [4] Gomez-Gomez A., Miranda J., Feixas G., Arranz Betegon A., Crispi F., Gratacós E., Pozo O.J., Determination of the Steroid Profile in Alternative Matrices by Liquid Chromatography Tandem Mass Spectrometry, J. Steroid Biochem. Mol. Biol., 197 (2020) 105520.
  • [5] Sayeed I., Wali B., Guthrie D.B., Saindane M.T., Natchus M.G., Liotta D.C., Stein D.G., Development of a Novel Progesterone Analog in the Treatment of Traumatic Brain Injury, Neuropharmacology, 145 (2019) 292-298.
  • [6] Struk W.R., Progestogens in Hormonal Replacement Therapy: New Molecules, Risks, and Benefits, Menopause 9 (2002) 6-15.
  • [7] Belchetz PE., Hormonal Treatment of Postmenopausal Women, N. Engl. J. Med., 330 (1994) 1062-1071.
  • [8] Kawaguchi M., Takatsu A., Miniaturized Hollow Fiber Assisted Liquid-Phase Microextraction and Gas Chromatography-Mass Spectrometry for the Measurement of Progesterone in Human Serum, J. Chromatogr. B., 877 (2009) 343-346.
  • [9] Ishibashi M., Takayama H., Nakagawa Y., Harima N., Diethylhydrogensilyl-Cyclic Diethylsilylene Derivatives in Gas Chromatography/Mass Spectrometry of Hydroxylated Steroids. Analysis of Cortisol and 6 Beta-Hydroxycortisol in Human Urine, Chem. Pharm. Bull., 36 (1988) 845-848.
  • [10] Ichimiya H., Egestad B., Nazer H., Baginski E.S., Clayton P.T., Sjövall J., Bile Acids and Bile Alcohols in a Child with Hepatic 3 Beta-Hydroxy-Delta 5-C27-Steroid Dehydrogenase Deficiency: Effects of Chenodeoxycholic Acid Treatment, J. Lipid Research, 32 (1991) 829-841.
  • [11] Setchell K.D., Suchy F.J., Welsh M.B., Zimmer-Nechemias L., Heubi J., Balistreri W.F., Delta 4-3-Oxosteroid 5 Beta-Reductase Deficiency Described in Identical Twins with Neonatal Hepatitis. A New Inborn Error in Bile Acid Synthesis, The J. Clin. Invest., 82 (1988) 2148-2157.
  • [12] Meng L.J., Sjövall J., Method for Combined Analysis of Profiles of Conjugated Progesterone Metabolites and Bile Acids in Serum and Urine of Pregnant Women, J. Chromatogr. B., 688 (1997) 11-26.
  • [13] British Pharmacopoeia, British Pharmacopeia Commission, London, (2000) 2197.
  • [14] Shi Y., Yao J., Liu F., Hu C., Yuan J., Zhang Q., Jin S., Establishment of an HPLC Identification System for Detection of Counterfeit Steroidal Drugs, J. Pharm. Biomed. Anal., 46 (2008) 663-669.
  • [15] De Orsi D., Pellegrini M., Pichini S., Mattioli D., Marchei E., Gagliardi L., High-Performance Liquid Chromatography-Diode Array and Electrospray-Mass Spectrometry Analysis of Non-Allowed Substances in Cosmetic Products for Preventing Hair Loss and Other Hormone-Dependent Skin Diseases, J. Pharm. Biomed. Anal., (2008) 48641-648.
  • [16] Alambiaga-Caravaca A.M., Domenech-Monsell I.M., Sebastián-Morelló M., Miranda M., Balaguer-Fernández C., Calatayud-Pascual A., Rodilla V., López-Castellano A., HPLC-UV Analytical Validation of a Method for Quantification of Progesterone in Ex Vivo Trans-Corneal and Trans-Scleral Diffusion Studies, J. Pharm. Biomed. Anal., 193 (2021) 113749.
  • [17] Sun L., Zhang B., Sun J., The Solubility-Permeability Trade-Off of Progesterone with Cyclodextrins under Physiological Conditions: Experimental Observations and Computer Simulations, J. Pharm. Sci., 107 (2018) 488-494.
  • [18] Maliwal D., Jain P., Jain A., Patidar V., Determination of Progesterone in Capsules by High-Performance Liquid Chromatography and UV-Spectrophotometry, J. Young Pharmacist., (2009) 1371-374.
  • [19] Pucci V., Bugamelli F., Mandrioli R., Luppi B., Raggi M.A., Determination of Progesterone in Commercial Formulations and in Non Conventional Micellar Systems, J. Pharm. Biomed. Anal., 30 (2003) 1549-1559.
  • [20] El-Yazbi F.A., Korany M.A., Abdel-Razzak O., Elsayed M.A., Derivative Spectrophotometric Analysis of Oestradiol Esters, Testosterone and Progesterone in Oily Injections, Anal. Lett., 18 (1985) 2127-2142.
  • [21] The European Agency for the Evaluation of Medicinal Products. ICH Topic Q2B Note for Guideline on Validation of Analytical Procedures: Methodology GPMP/ICH/281/95 (1996).
  • [22] United States Pharmacopeia, 23th ed., Rockville United States: Pharmacopeial Convention, Inc., (1995).
There are 22 citations in total.

Details

Primary Language English
Subjects Analytical Biochemistry
Journal Section Natural Sciences
Authors

Bilal Yılmaz 0000-0002-8574-7570

Mevlüt Albayrak 0000-0001-8673-6577

Yücel Kadıoğlu 0000-0001-6590-7306

Publication Date September 29, 2023
Submission Date May 26, 2023
Acceptance Date September 13, 2023
Published in Issue Year 2023

Cite

APA Yılmaz, B., Albayrak, M., & Kadıoğlu, Y. (2023). Determination of Progesterone in Pharmaceutical Preparations by UV, First-order Derivative Spectrophotometry and Gas Chromatography. Cumhuriyet Science Journal, 44(3), 456-463. https://doi.org/10.17776/csj.1303270