Abstract
The UPLC technique we have developed is completely unique and reliable and can quantitatively measure drospirenone and estetrol (E4) simultaneously. The chromatographic column of Luna C18 (100 × 2.6 mm, 1.6 µ) and isocratic elution, with a buffer (0.1% formic acid) and acetonitrile (30:70 v/v), using a flow of 1 ml/minutes at room temperature was used. The process was monitored by ultraviolet detection at 262 nm. A total of 3 minutes was dedicated to using a 3-minute timer to separate drospirenone and E4. Within the concentration range from 3 to 45 µg/ml of drospirenone and 14.2–213 µg/ml of E4, the analysis was completed in less than 5 minutes. System suitability parameters were studied and the outcomes were within acceptable limits when they were injected with the standard six times. To confirm the safety of the formulated product, a market-bought solution was assayed and it was found to be within specification. With all conditions and the acceptable range allowed, degradation studies were carried out on drospirenone and E4, all of which came back with a purity threshold that was higher than the purity angle. This particular technique was found to be consistent with the guidelines set forth by the International Council on Harmonization.
Highlights
Progestin (Wiegratz and Kuhl, 2004) medications, like drospirenone, are used in birth control pills to prevent pregnancies and are included in hormone replacement therapy (Langer et al, 2021; Stuenkel et al, 2015) for menopausal women, among other applications (Kuhl, 2005)
The UPLC technique we have developed is completely unique and reliable and can quantitatively measure drospirenone and estetrol (E4) simultaneously
The present study shows the simultaneous estimation of drospirenone and E4 using UPLC because UPLC allows for better separation and very fast analysis than the HPLC
Summary
Progestin (Wiegratz and Kuhl, 2004) medications, like drospirenone, are used in birth control pills to prevent pregnancies and are included in hormone replacement therapy (Langer et al, 2021; Stuenkel et al, 2015) for menopausal women, among other applications (Kuhl, 2005) It is available solely under the brand name Slynd, but it is available in combination with estrogen (or other hormones) under the brand name Yasmin, as well as many other brands. The following are the most common side effects: acne (Scott et al, 2019), headache, breast tenderness (Salzman et al, 2012), weight gain, and menstrual changes (Atteson and Zaluski, 2019; Catalini and Fedder, 2020).
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