Forced degradation of mometasone furoate and development of two RP-HPLC methods for its determination with formoterol fumarate or salicylic acid

Abstract

Two simple, selective and precise stability-indicating reversed-phase liquid chromatographic methods were developed and validated for the determination of mometasone furoate in two binary mixtures, with formoterol fumarate (Mixture 1) and salicylic acid (Mixture 2). Also, a forced degradation study of mometasone furoate was carried out including acid and alkali hydrolysis, oxidation, thermal and photo-degradation. For mixture 1, the method was based on isocratic elution using a mobile phase consisting of (Acetonitrile: 3 mM Sodium lauryl sulfate) (60:40, v/v) at a flow rate of 1 ml min À1 . Quantitation was achieved applying dual wavelength detection where mometasone furoate and its degradation products were detected at 247 nm and formoterol fumarate and its degradation product were detected at 214 nm at 30°C. For mixture 2 and for the forced degradation study, separation was based on isocratic elution of mometasone furoate, its degradation products and salicylic acid on a reversed phase C8 column using a mobile phase consisting of acetonitrile:water:methanol:glacial acetic acid (60:30:10:0.1, v/v) at a flow rate of 2 mL min À1 . Quantitation was achieved with UV detection at 240 nm. In addition, products from alkaline forced degradation of mometasone furoate were verified by LC-MS. Linearity, accuracy and precision were found to be acceptable over the concentration range of 10-800 lg mL À1 and 5-60 lg mL À1 for mometasone furoate and formoterol fumarate, respectively and over the concentration range of 5-320 lg mL À1 and 20-1280 lg mL À1 for mometasone furoate and salicylic acid,

Development of simple and fast UV-method for the quantitative determination of mometasone furoate in a large number of metered doses of an aqueous nasal spray of mometasone furoate

“…The proposed approach is applicable for quantitative determination of analyte(s) in tested solutions with turbidity. Let us consider alternative approaches:Methods that are based on physical separation of analyte from interfering substances of sample matrix (gone into the mentioned tested solution) [9, 10, 11, 12, 13] have the following disadvantages when compared with the proposed approach:Require a preliminary separation of particles, the presence of which is causing the turbidity (e.g. by filtration or centrifugation);Require by an order more time for running the final analytical operation - chromatography (HPLC) as compared with the final analytical operation - spectrophotometry.…”

“…There are many excellent works on MF quantitative determination in various pharmaceuticals by HPLC [9, 10, 11, 12, 13, 16] with UV detection. Apparently, HPLC-MS2 (and higher, with APCI, APPI) is the most powerful tool for quantitative determination of MF and its metabolites in blood plasma and other biological objects [14].…”

“…In some papers [13, 15], TLC with densitometric UV detection was used for quantification of MF. In most cases [10, 11, 12, 13], chromatographic techniques were used to quantify MF as well as one or more additional analytes in drugs, whereas in paper [9], only MF is defined. The latter could be explained by the fact that the developed technique is universally applicable to both creams and nasal MF sprays.…”

Simple development and validation of RP-HPLC and TLC- densitometric methods for the simultaneous determination of nadifloxacine and mometasone furoate in their binary mixture

“…A mixture of ND and MF are available in cream dosage firms which topically applied for the treatment of dermatoses. Literature surveys revealed that ND is not official in any pharmacopoeia [3] while MF is an official drug in European Pharmacopoeia [4].The literature survey revealed several analytical methods have been reported for the determination of ND alone or in combinations with other drugs including, spectrophotometry [5,6], HPTLC [7,8]HPLC [9][10][11], Different methods were reported for determination of MF alone or in combinations with other drugs including, spectrophotometry, [12][13][14],TLC [8,15]and HPLC [16][17][18][19][20][21][22] To the best of author's knowledge there is only one method has been reported for the determination of ND and MF in combinations using HPTLC technique [23]. The work in this paper was aimed to develop two selective, accurate and precise chromatographic methods for the simultaneous determination of ND and MF in topical cream.…”

A validated spectrophotometric method for determination of formoterol fumarate dihydrate in bulk and dosage form using methyl orange as ion pair reagent

“…Some analytical methods for quantitative determination of formoterol fumarate in biological fluids by LC-MS/MS (3,4). a survey of the literature also revealed that a few analytical methods have been reported for the determination of formoterol fumarate by HPLC (5)(6)(7)(8)(9)(10), capillary electrophoresis (11), capillary electrophoresis with laser induced fluorescence after derivatization (12), derivative spectroscopic method for dosage form (13) spectrophotometry (14)(15), chiral HPLC method (16), gas chromatography (17), HPTLC (18), quantitative nMr (19) for pure and pharmaceutical forms. But no ion pair extraction method has been reported for formoterol fumarate dihydrate.…”