Quantification of Ethinyl Estradiol, Levonorgestrel and Ferrous Fumarate from Bulk Drugs and Tablet Formulation using a Validated HPLC Method
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Abstract
Objective: This research article introduces new, rapid, accurate and precise HPLC method for estimating Ethinyl estradiol, Levonorgestrel and Ferrous fumarate from the bulk drug and tablets.
Methods: HPLC analysis of all the three drugs was performed on the Sun Q sil C18, (250 mm x 4.6 mm ID, 5 µm) under isocratic conditions employing mobile phase as acetonitrile: water in ratio of 70: 30 at flow rate of 0.7 mL/min with UV wavelength of 265 nm.
Results: Ferrous fumarate, Ethinyl estradiol, and Levonorgestrel had retention times of 2.86 min, 6.66 min and 9.87 min, respectively. The data from linear regression analysis studies was plotted and calibration plots demonstrated satisfactory linear connection. For Ethinyl estradiol, Levonorgestrel, and Ferrous fumarate, the mean correlation coefficient values were found to be 0.9997, 0.9992 and 0.9995. % RSD for intra-day precision and inter-day precision was found to be less than 2. Accuracy was found to be 99.58 % for Ethinyl estradiol, 99.85 % for Levonorgestrel and 100.06 % for Ferrous fumarate and the method was found to be specific.
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References
PubChem [Internet]. Bethesda (MD) (2004): National Library of Medicine (US), National Center for Biotechnology Information, PubChem Compound Summary for CID 5991,ethinyl estradiol.
Bebb R.A., Anawalt B.D., Christensen R.B., Paulsen C.A., Bremner W.J. and Matsumoto A.M. (1996). Combined administration of Levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab., 81(2):757-62.
Georgieff M.K., Krebs N.F. and Cusick S.E. (2019). The Benefits and Risks of Iron Supplementation in Pregnancy and Childhood. Annu Rev Nutr., 39:121-146.
Bhusari V.K. and Dhaneshwar S.R. (2012). Validated HPTLC method for simultaneous estimation of Ethinyl estradiol and Drospirenone in bulk drug and formulation. Reviews in Analytical Chemistry, 31(2):123-129.
Fakhari A.R., Khorrami A.R. and Shamsipur M. (2006). Stability-indicating high-performance thin-layer chromatographic determination of Levonorgestrel and Ethinyl estradiol in bulk drug and in low-dosage oral contraceptives. Anal. Chim. Acta., 572(2):237–242.
Pradad G.R., Babu P.S. and Ramana M.V. (2011). Validated RP-HPLC method for the estimation of drospirenone in formulation. Int. J. Res. Pharm. Biomed. Sci., 2(2):1341–1345.
Prasad S.D., Reddy G.C., Prasad P.S.S. and Mukkanti K. (2004). Simultaneous HPLC estimation of Levonorgestrel and Ethinyl estradiol from tablets. Indian J. Pharm. Sci., 66(2):231- 234.
Prabhakar B. and Deshpande S. (1999). Simultaneous estimation of Ethinyl estradiol and Levonorgestrel from transdermal patches by HPLC. Semantic scholar, Indian J. of Pharma. Sci., 61(1):12-15.
Borges N.C., Astigarraga R.B., Sverdloff C.E., Galvinas P.R., Silva W.M.D., Rezende V.M. and Moreno R.A. (2009). A novel and sensitive method for ethinyl estradiol quantification in human plasma by high-performance liquid chromatography coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry: application to a comparative pharmacokinetics study. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 877(29):3601– 3609.
ICH guidelines for validation of analytical procedures: text and methodology Q2(R1).
ICH guidelines for validation of analytical procedures: text and methodology Q2(R2).
European Pharmacopoeia 5.0. (n.d.). Retrieved June 22, 2023.