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Synthetic Prostaglandins are analogs or derivatives of prostaglandins that do
not occur naturally in the body. They do not include the product of the chemical
synthesis of hormonal PGE. Synthetic prostaglandins are used to induce childbirth
(parturition) or abortion, to prevent closure of patent ductus arterious in new borns
with particular cyanotic heart defects, to prevent and treat peptic ulcers, as a
vasodilator in ischemia, in pulmonary hypertension, in treatment of glucoma, to treat
erctile dysfunction and used as an ingredient in eyelash and eyebrow growth beauty
products.
Synthetic prostaglandins namely misoprostol, enprostil, rioprostil, arabaprostil,
metenoprost, lubiprostone etc.
A steroid is a type of organic compound that contains a specific arrangement of
four rings that are joined to each other. Examples of steroids include cholesterol,
the sex hormones estradiol and testosterone, and the anti-inflammatory drug
dexamethasone.
Biequivalence studies play an important role is establishing invivo equivalence and
most of the synthetic prostaglandins and steroids bioanalytical method development
is challenging due to low dose formulation demand of sensitive methods and stability
issues.
In detail discussion on factors meeting consideration of MS/MS measurements
of steroids and prostaglandins are presented, chromatographic conditions,
instrumentation information like HPLC, LCMS detection parameters, sample
preparations, recovery details, limit of detection and limit of quantification, Tmax,
Cmax etc, for application in BA/BE studies of pharmaceuticals was incorporated in
the current presentation.
4 case studies 2 from each category are depicted.
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