Abstract
abstract A simple stability-indicating RP-HPLC/UV method was validated for determination of beclomethasone dipropionate (BD) in nanocapsule suspensions. Chromatographic conditions consisted of a RP C18column (250 mm x 4.60 mm, 5 µm, 110 Å), using methanol and water (85:15 v/v) as mobile phase at 1.0 mL/min with UV detection at 254 nm. The calibration curve was found to be linear in the concentration range of 5.0-25.0 µg/mL with a correlation coefficient > 0.999. Precision was demonstrated by a relative standard deviation lower than 2.0%. Accuracy was assessed by the recovery test of BD from nanocapsules (98.03% to 100.35%). Specificity showed no interference from the components of nanocapsules or from the degradation products derived from acid, basic and photolytic conditions. In conclusion, the method is suitable to be applied to assay BD in bulk drug and in nanocapsules, and it can be employed to study stability and degradation kinetics.
Highlights
Beclomethasone dipropionate (BD; C38H28ClO7; MW: 521.0 Da) (Figure 1), a synthetic chlorinated glucocorticoid diester, is a well-established antiinflammatory agent used in the treatment of asthma (Vidgren et al, 1995)
BD is characterized by a white or
According to the stability guideline of the International Conference on Harmonization (ICH, 2003), stress testing of a drug substance can be carried out to elucidate its inherent stability characteristics under hydrolytic, oxidative and photolytic conditions. Taking all of this into account, in the present study, a simple reverse-phase HPLC method with UV detection was validated for quantifying BD in nanocapsules, as well as to study forced degradation of the drug under stress conditions
Summary
Beclomethasone dipropionate (BD; C38H28ClO7; MW: 521.0 Da) (Figure 1), a synthetic chlorinated glucocorticoid diester, is a well-established antiinflammatory agent used in the treatment of asthma (Vidgren et al, 1995). The advantages of using such colloidal carriers include: potential to increase the bioavailability of poorly water-soluble drugs, ability to control the rate and/or the site of drug release and possibility to improve drug stability related to enzymatic, immunological or chemical/photochemical degradation, among others (Couvreur, Vauthier, 2006) In this way, experiments are being conducted in our laboratory in order to formulate BD-loaded biodegradable nanocapsules. According to the stability guideline of the International Conference on Harmonization (ICH, 2003), stress testing of a drug substance can be carried out to elucidate its inherent stability characteristics under hydrolytic, oxidative and photolytic conditions Taking all of this into account, in the present study, a simple reverse-phase HPLC method with UV detection was validated for quantifying BD in nanocapsules, as well as to study forced degradation of the drug under stress conditions. It is relevant to mention that the method developed in our work is easy, low cost and employ few raw materials to quantify BD in nanocapsules
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