An HPLC method to evaluate purity of a steroidal drug, loteprednol etabonate

Genotoxic Impurities in Pharmaceuticals

“…Epoxides/hydroperoxides were analyzed using HPLC, and simple RPLC methods employing direct analysis (no sample preparation) were used for some of them. Yasueda et al (2004) described an HPLC method for the determination of loteprednol impurities including a minor photolytic epoxide degradation product. Lacroix et al (1992) reported an HPLC method for the determination of related substances, including the epoxide impurity of nadalol.…”

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

“…Other stability indicating HPLC methods were published for the assay of budesonide [13], medroxyprogesterone acetate [14], loteprednol etabonate [15], examestane [16], etiprednol dicloacetate [17], eplerenone [18], dutasteride [19,20], estradiol [21], betamethasone [22] and intermediates in steroid syntheses such as alphamethylepoxide (16␣-methyl-1,4-pregnadiene-9␤,11␤-oxide-17␣,21-diol-3,20-dione) [23] and its 16␤-methyl analogue, betamethylepoxide [24].…”

“…An example for this is the monograph of fulvestrant in USP 33 [9] where these data for five potential impurities are presented. This approach can be found in the papers already mentioned in connection with the stability-indicating assays [13][14][15][16][17][18][19][20][21][22][23][24].…”

Analytical approaches for the detection of epoxides and hydroperoxides in active pharmaceutical ingredients, drug products and herbals

“…Yasueda et al [8] described an HPLC method for the determination of loteprednol impurities, including that of a minor photolytic epoxide degradation product in loteprednol etabonate API.…”