Comparison of OPLC and other chromatographic methods (TLC, HPLC, and GC) for in-process purity testing of nandrolone

Simple and Accurate HPTLC-Densitometric Method for Assay of Nandrolone Decanoate in Pharmaceutical Formulation

“…Importantly, it does not need any tedious cleanup of the sample. The comparison of different chromatographic techniques such as TLC, as well as OPLC (over-pressured layer chromatography), methods in the purity control of nandrolone was reported by Bagocsi et al [16]. It was stated that thin-layer chromatography was not a selective method in this study, and the applied OPLC analysis required multiple development of chromatographic plates and the use of visualizing reagent in the form of sulfuric acid.…”

“…UV-Vis detection was performed at λ = 240 nm [6]. Our previous studies and the papers prepared by other researchers confirm also the utility of thin-layer chromatography (TLC) for the purpose of separation and quantitative analysis of various steroids, including selected anabolic-androgenic agents [7,8,9,10,11,12,13,14,15,16,17], because of its simplicity, low cost, and relatively low detection limit compared to other more modern chromatographic methods, such HPLC with different detection systems. Importantly, it does not need any tedious cleanup of the sample.…”

Overpressured Layer Chromatography (OPLC) – A Flexible Tool of Analysis and Isolation

“…The semi-quantitative OPLC method is an economical and fast limit test and can be used for in-process validation, where its accuracy is sufficient, but the rapidity of the analysis is important. The OPLC method developed has been applied for in-process purity testing of Nandrolone and has been compared with other chromatographic methods (TLC, HPLC and GC) ( Figure 7) [63].…”

“…1) Nandrolone, 2) 5α-4,5-Dihydronandrolone, 3) Nandrolone Δ 5(10) -isomer, 4) 8,14-Didehydronandrolone, 5) Dienolether, 6) 6β-Hydroxy-nandrolone, 7) Estradiol methylether. (Reproduced from Ref [63],. with permission.…”

Recent Advances in the Analysis of Steroid Hormones and Related Drugs

“…As a result of these factors, OPLC is eminently suitable for the separation of impurities and degradants in bulk drugs and their formulations. Examples for the application of OPLC to steroid hormone drugs are the purity test of norgestrel and levonorgestrel (visualization by fluorescence quenching at 254 nm, phosphomolybdic acid or sulfuric acid), 77 allylestrenol drug substance and tablet (sulfuric acid), 78 nandrolone (sulfuric acid; comparison of the impurity profile with those obtained by TLC, HPLC and GC), 79 norethisterone drug substance and tablet (sulfuric acid). 80 OPLC was successfully used in in-process-monitoring 81 and cleaning validation of equipment 82 in the course of the production of bulk steroids and steroid formulations.…”