Betamethasone hydrochloride

Betamethasone is a synthetic corticosteroid and agonist of glucocorticoid receptor [1].

Betamethasone has shown the inflammatory response by the betamethasone-receptor complex modulated the activity of certain genes, altering the production and activity of proteins. These proteins include phospholipase A2, cyclooxygenase-2 and NO-synthase. Betamethasone has been reported to inhibit the expression of these enzymes results in reduced production of such inflammatory mediators as prostaglandins, leukotrienes and nitric oxide. In addition betamethasone has also revealed to inhibit keratinocyte proliferation [1].

References:
[1] Pharmacology Review(s)-FDA.

http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021852s000_PharmR.pdf

RP-HPLC method for simultaneous determination of butenafine hydrochloride and betamethasone dipropionate in a cream formulation.[Pubmed:21391486]

J AOAC Int. 2011 Jan-Feb;94(1):106-9.

An RP-HPLC method has been developed for the simultaneous determination of butenafine hydrochloride and betamethasone dipropionate on an Inertsil C18 column (250 x 4.6 mm id) using a mobile phase gradient consisting of methanol and water at a flow rate of 1 mL/min. Detection was carried out at 254 nm. Retention times of betamethasone dipropionate and butenafine hydrochloride were 4.82 (+/- 0.80) and 16.18 (+/- 0.17) min, respectively. The method was validated with respect to specificity, linearity, accuracy, precision, ruggedness, and robustness. This method is simple, precise, and sensitive, and applicable for the simultaneous quantification of butenafine hydrochloride and betamethasone dipropionate in a cream formulation.

Simultaneous Determination of Cinchocaine Hydrochloride and Betamethasone Valerate in Presence of Their Degradation Products.[Pubmed:28168304]

J Chromatogr Sci. 2017 May 1;55(5):518-527.

Cinchocaine hydrochloride (CIN) and betamethasone valerate (BMV) are co-formulated in pharmaceutical formulations that could be used for local treatment of hemorrhoids. Both drugs are susceptible to hydrolytic degradation. Two sensitive and precise stability-indicating chromatographic methods were developed for the simultaneous determination of both active pharmaceutical ingredients. The developed methods were applied for quantitation of CIN and BMV in their pure forms, in presence of their corresponding degradation products and in their pharmaceutical formulation. The first method was a high performance liquid chromatographic (HPLC) one, separation and quantitation was achieved using a Waters Spheriosorb(R) 5 mum ODS2 C18 analytical column and an isocratic mobile phase formed of acetonitrile-acetate buffer (pH 6.5 +/- 0.1) in a ratio of (55:45, v/v). The mobile phase was pumped at a flow rate of 1.2 mL/min. UV-detection was done at 240 nm using photodiode array detector. The second method was based on thin layer chromatography (TLC) fractionation coupled with densitometric determination. Separation was done on high performance thin layer chromatography (HPTLC) silica gel 60F254 plates using a developing system formed of chloroform-toluene-ethanol-acetic acid in a ratio of (4.5:4.5:1:1, by volume). The separated bands were scanned densitometrically at 240 nm. For the HPLC method, linearity was confirmed over concentration ranges of 4-300 and 4-350 mug/mL for CIN and BMV, respectively. For the HPTLC-densitometric method, the obtained ranges were 0.5-12 and 0.5-10 mug/band for CIN and BMV, respectively. The developed methods were optimized and validated according to the ICH guidelines. CIN acid degradation products were separated and identified by mass spectroscopy. The developed HPLC method was used to study the kinetics of acid and alkali degradation of the both drugs. The results obtained were statistically analyzed and compared with those obtained by applying the official methods for both drugs.

Simultaneous HPLC determination of butenafine hydrochloride and betamethasone in a cream formulation.[Pubmed:20502575]

Indian J Pharm Sci. 2009 Sep;71(5):547-51.

A fast, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of butenafine hydrochloride and betamethasone in cream formulation. The determination was carried out on licrocart licrosphere RP-select B (250x4.6 mm, 5 mu) column in isocratic mode, the mobile phase consisting of 50 mM ammonium acetate buffer and acetonitrile in the ratio of 60:40, adjusted to pH 4.5 +/- 0.1 with glacial acetic acid. The flow rate was 2.0 ml/min and eluent was monitored at 254 nm. The retention times of butenafine hydrochloride and betamethasone were 4.70 min and 7.76 min, respectively, and the resolution factor was greater than 4.0. Linearity of butenafine hydrochloride and betamethasone were in the range of 100-300 mug/ml and 5-15 mug/ml, respectively. The proposed method is also found to be precise and robust for the simultaneous determination of butenafine hydrochloride and betamethasone in cream formulation.

In Vivo performance of ophthalmic preparations of betamethasone and phenylephrine hydrochloride in the rabbit eye: Effect of polyvinyl alcohol.[Pubmed:24271590]

Pharm Res. 1986 Aug;3(4):244-8.

The effect of different concentrations of polyvinyl alcohol 14000 and 72000 (PVA 14 and 72) on the activity of betamethasone and phenylephrine hydrochloride in the rabbit eye was investigated. The polymer of higher molecular weight exerts a more pronounced effect at relatively lower viscosities. Effects on the intraocular pressure are more responsive to changes in viscosity than those on pupillary response.