Simultaneous Determination of Gestodene and Ethinyl Estradiol in Contraceptive Formulations by RP‐HPLC

Laban, Aleksandra; Marković, S.; Stankov, Milena Jelikić; Djurdjević, Predrag

doi:10.1081/al-120027792

Cited by 15 publications

(7 citation statements)

References 15 publications

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“…These stability-indicating methods are almost exclusively RP-HPLC methods with UV detection. The determination of betamethasone [67], betamethasone dipropionate [68], budesonide [69], clobetasol propionate [70], deflazacort [71], dexamethasone [71][72][73][74], dexamethasone acetate [75], dexamethasone sodium phosphate [72,76], diflucortolone valerate [77], dutasteride [19], eplerenone [18], estradiol [21,78,79], ethinylestradiol [80], fluocinolone acetonide [81], finasteride [82], fluticasone propionate [83], gestodene [80], medroxyprogesterone acetate [14], meprednisone [84], mometasone furoate [85], testosterone propionate and cypionate [86] and triamcinolone acetonide [87] in various solid, semi-solid and liquid formulations have been described. The on-line assay of beclomethasone propionate pressurized metered dose inhalers [88] and the determination of the solubility of beclomethasone propionate [89] and budesonide [90] in the same device are also worth mentioning.…”

Section: Hplc Methodsmentioning

confidence: 99%

Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004–2010)

Gǒrög

2011

Journal of Pharmaceutical and Biomedical Analysis

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Section: Hplc Methodsmentioning

confidence: 99%

Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004–2010)

Gǒrög

2011

Journal of Pharmaceutical and Biomedical Analysis

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“…Another RP-HPLC method was developed for the concurrent analysis of 17-beta-estradiol and Drosp in combined dosage form [7]. Moreover, numerous analytical methods were developed for the determination of EE alone in dosage form or in human plasma including spectrophotometric methods [8][9][10][11][12][13][14][15], HPTLC methods [16][17][18], liquid chromatographic methods [14,[19][20][21][22][23][24][25][26][27][28][29][30][31][32][33], micellar electrokinetic capillary chromatography (MEKC) [34,35], spectrofluorometric methods [36,37] and voltammetric techniques [38,39]. Moreover, few analytical techniques were developed for the simultaneous estimation of the studied drugs in tablet formulations including an HPTLC method [40] and chromatographic methods including an official one in United States Pharmacopoeia (USP) [41][42][43][44][45][46].…”

Section: Introductionmentioning

confidence: 99%

Square-wave voltammetric determination of drospirenone and ethinylestradiol in pharmaceutical dosage form using square wave technique

et al. 2019

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Cathodic voltammetric behaviors of drospirenone and ethinylestradiol were used for the simultaneous determination of both drugs in bulk and in pharmaceutical formulation (Yasmin® tablets) without the interference of excipients. The determinations were made on hanging mercury dropping electrode using square-wave technique in a voltammetric cell containing 10 mL of 0.04 mole/L Britton-Robinson. After every aliquot addition, the solution was stirred for 10 s at 1000 rpm, rested for 10 s then square wave voltammetry mode was ramped from +100 to -1700 mV with scan rate of 100 mV/s, pulse amplitude of 50 mV and measurement time of 5 ms. Several factors such as pH, type of supporting electrolyte, pulse amplitude and scan rate were studied to optimize the condition for voltammetric determination of these drugs. With optimized experimental parameters, a good linearity was obtained for both drugs over a range of 1.36×10-6 to 1.91×10-7 mole/L and 6.75×10-8 to 6.07×10-7 mol/L of drospirenone and ethinylestradiol, respectively. Characterization of the proposed method was done according to International Conference on Harmonization, Q2B: Validation of Analytical procedures. The proposed method was statistically compared with the reference method and the results revealed no significant difference regarding accuracy and precision.

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“…Utilized technologies included UV spectrophotometry [11][12][13][14], voltammetry [15,16], liquid chromatography with UV detection [17][18][19][20][21], gas chromatography [22,23], radioimmunoassays (RIA) [24][25][26][27][28][29], and liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) [30][31][32][33][34][35][36][37][38][39][40][41][42][43]. For many years, RIA methods, often applied in pharmacokinetic studies, have been the most sensitive analytical procedures for the determination of synthetic progestins in biological samples.…”

Section: Introductionmentioning

confidence: 99%

Simultaneous online SPE-LC-MS/MS quantification of six widely used synthetic progestins in human plasma

et al. 2011

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Co-administration of synthetic progestin containing hormonal contraceptives (HCs) and antiepileptic drugs (AEDs) is a common clinical situation which needs specific considerations due to drug interactions. Several studies have demonstrated that lamotrigine plasma levels are significantly decreased during co-medication with HCs, and that this interaction is associated with increased seizure frequency in most of the cases. Additionally, an increase in contraceptive failure and unintended pregnancy could be observed during co-medication. Hence, monitoring of progestin plasma levels in patients with AED co-medication is of interest. A rapid and reliable online solid-phase extraction-high performance liquid chromatography-tandem mass spectrometry (online SPE-LC-MS/MS) method using gradient elution in the LC domain was established and validated for the simultaneous quantitative determination of gestodene, dienogest, drospirenone, etonogestrel, cyproterone acetate, and levonorgestrel in human plasma. The online SPE-LC-MS/MS method covered a quantification concentration range of 5-100 ng/ml for dienogest, 1-100 ng/ml for etonogestrel and 2-100 ng/ml for all other analytes. Stable isotope-labeled internal standards were used for analyte quantification based on selected reaction monitoring experiments. Inter- and intra-assay precision and accuracy were determined from quality control (QC) samples at the lower limits of quantification and at low, medium, and high concentration levels within the calibration range. Inter-assay reproducibility at the QC levels was better than 10% (relative standard deviation, RSD), accuracy at these levels ranged from -3.7% to 11.3%. Total extraction efficiency, tested at three concentrations, ranged from 92.5% to 106.4%. Matrix interferences were excluded by post-column infusion experiments. To prove the applicability of the assay in clinical cohorts, a sample set (n = 298) stemming from study patients under AED/oral HC co-medication was screened for progestin plasma levels. This method has to be considered a research-use-only assay and must not be used for diagnostic or therapeutic purposes, since it did not undergo formal performance evaluation in the sense of the IVD directive (98/79/EG) of the European Community.

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Simultaneous Determination of Gestodene and Ethinyl Estradiol in Contraceptive Formulations by RP‐HPLC

Cited by 15 publications

References 15 publications

Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004–2010)

Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004–2010)

Square-wave voltammetric determination of drospirenone and ethinylestradiol in pharmaceutical dosage form using square wave technique

Simultaneous online SPE-LC-MS/MS quantification of six widely used synthetic progestins in human plasma

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