Search results for: Abu M. Rustum

Items from 1 to 20 out of 22 results

article

A compatibility study of a secondary amine active pharmaceutical ingredient with starch: Identification of a novel degradant formed between desloratadine and a starch impurity using LC–MSⁿ and NMR spectroscopy

Xin Yu, Alexei V. Buevich, Min Li, Xin Wang, more

Journal of Pharmaceutical Sciences > 102 > 2 > 717 - 731

Active pharmaceutical ingredients (APIs) containing primary and secondary amine moieties have been extensively studied for their potential incompatibility with monosaccharides and disaccharides containing a reducing end such as glucose, lactose, and maltose because of the undesirable interaction between the amine and aldehyde functionalities. Compatibility studies of these APIs with olysaccharides...

article

A general static-headspace gas chromatographic method for determination of residual benzene in oral liquid pharmaceutical products

Hui Liu, Qinglin Tang, Robert J. Markovich, Abu M. Rustum

Journal of Pharmaceutical and Biomedical Analysis > 2011 > 54 > 2 > 417-421

Sodium benzoate is used in oral liquid pharmaceutical products for its anti-microbial properties. The benzoate salts present in liquid pharmaceutical products can potentially generate residual levels of free benzene during manufacturing of the drug product and or during the shelf-life of the product under its storage conditions. To ensure the safety and quality of the pharmaceutical products (containing...

article

Static headspace gas chromatographic method for the determination of low and high boiling residual solvents in Betamethasone valerate

Jayalakshmi Somuramasami, Yu-Chien Wei, Emad F. Soliman, Abu M. Rustum

Journal of Pharmaceutical and Biomedical Analysis > 2011 > 54 > 1 > 242-247

Currently, there are no analytical methods available in the literature that can simultaneously separate and quantitate residual levels of acetone, methylene chloride, n-butyl ether and dimethylsulfoxide in Betamethasone valerate active pharmaceutical ingredient (API). This paper describes the development and validation of a simple, efficient, accurate and robust static headspace gas chromatography...

article

A stability-indicating reversed-phase high performance liquid chromatography method for simultaneous assay of two corticosteroids and estimation of their related compounds in a pharmaceutical injectable formulation

Jun Lu, Yuchien Wei, Abu M. Rustum

Journal of Chromatography A > 2010 > 1217 > 44 > 6932-6941

Betamethasone Sodium Phosphate and Betamethasone Acetate are the two corticosteroids active pharmaceutical ingredients (APIs) that are present in the injectable formulation, Celestone Chronodose ^® Injection. It is extremely challenging to develop a Quality Control friendly HPLC method to separate all the potential impurities and degradation products of the two APIs from each other using a...

article

Thermally induced intramolecular oxygen migration of N‐oxides in atmospheric pressure chemical ionization mass spectrometry

Xin Wang, Min Li, Abu M. Rustum

Rapid Communications in Mass Spectrometry > 24 > 19 > 2805 - 2811

N‐Oxides are known to undergo three main thermal degradation reactions, namely deoxygenation, Cope elimination (for N‐oxides containing a β‐hydrogen) and Meisenheimer rearrangement, in atmospheric pressure chemical ionization mass spectrometry (APCI‐MS). The ions corresponding to these thermal degradants observed in the ensuing APCI mass spectra have been used to identify N‐oxides as well as to determine...

article

Separation of chiral primary amino compounds by forming a sandwiched complex in reversed-phase high performance liquid chromatography

Chen Zhang, Wei X. Huang, Zhi Chen, Abu M. Rustum

Journal of Chromatography A > 2010 > 1217 > 30 > 4965-4970

Separation of chiral primary amino compounds was efficiently achieved under reversed-phase high performance liquid chromatography (RP-HPLC) conditions using a mixture of non-chiral crown ether (18-crown-6) and dimethyl-β-cyclodextrin (DM-β-CD) in the mobile phase. Under these conditions, the amino group of the chiral compound was protonated in a low pH mobile phase, and then interacted with 18-crown-6...

article

Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds

Qiang Fu, Minshan Shou, Dwight Chien, Robert Markovich, more

Journal of Pharmaceutical and Biomedical Analysis > 2010 > 51 > 3 > 617-625

Betamethasone (9α-fluoro-16β-methylprednisolone) is one of the members of the corticosteriod family of active pharmaceutical ingredient (API), which is widely used as an anti-inflammatory agent and also as a starting material to manufacture various esters of betamethasone. A stability-indicating reverse-phase high performance liquid chromatography (RP-HPLC) method has been developed and validated...

article

Rapid separation of desloratadine and related compounds in solid pharmaceutical formulation using gradient ion-pair chromatography

Jinjian Zheng, Abu M. Rustum

Journal of Pharmaceutical and Biomedical Analysis > 2010 > 51 > 1 > 146-152

We reported the development of an ion-pair chromatographic method to separate desloratadine and all known related compounds in Clarinex Tablets, which use desloratadine as active pharmaceutical ingredient (API). For the first time, baseline separation for desloratadine and all known related compounds was achieved by utilizing a YMC-Pack Pro C ₁₈ column (150mm×4.6mm I.D., 3μm particle size,...

article

A Single RP-LC Method for the Determination of Benzalkonium Chloride and Its Potential Impurities in Benzalkonium Chloride Raw Material

Marina Santos, Min Li, Abu M. Rustum

Chromatographia > 2010 > 71 > 5-6 > 499-503

A simple and rapid RP-LC method was developed for routine analysis of benzalkonium chloride (BKC) and its impurities in benzalkonium chloride raw material. The method uses a short ACE 3 C₈ column (50 × 4.6 mm, 3 μm particle size) and a gradient mobile phase consisting of 0.025% trifluoroacetic acid in water/acetonitrile (90/10, v/v) as mobile phase A, and water/acetonitrile (30/70, v/v) as mobile...

article

Development of a Stability-Indicating RP-LC Method for Determination of Betamethasone Dipropionate and Estimation of Its Related Compounds in a Dermatological Pharmaceutical Product

Palwinder Kaur, Galinada Wilmer, Yu-Chien Wei, Abu M. Rustum

Chromatographia > 2010 > 71 > 9-10 > 805-814

A new stability-indicating reversed-phase LC method has been developed and validated for the assay and identification of betamethasone dipropionate and its related compounds in a dermatological pharmaceutical drug product, namely Diprolene Ointment. Separation of all the peaks of interest was achieved on a Symmetry Shield RP18 (100 mm × 4.6 mm, 3.5 µm) column using a gradient elution at a flow rate...

article

Use of high resolution LC–MSn analysis in conjunction with mechanism-based stress studies: Identification of asarinin, an impurity from sesame oil in an animal health product

Xin Wang, Yanan Peng, Min Li, Abu M. Rustum

Journal of Pharmaceutical and Biomedical Analysis > 2009 > 50 > 5 > 1015-1021

During analysis of certain stability batches of an animal health product, an unknown peak was found at a level above the identification thresholds set by VICH. This unknown species is extremely labile in the gas phase under normal electrospray ionization (ESI) mass spectrometric condition. Multiple ions were detected with no clear indication of which one is the molecular ion. To overcome this challenge,...

article

Comparison study of porous, fused-core, and monolithic silica-based C18 HPLC columns for Celestoderm-V Ointment® analysis

Jinjian Zheng, Dolly Patel, Qinglin Tang, Robert J. Markovich, more

Journal of Pharmaceutical and Biomedical Analysis > 2009 > 50 > 5 > 815-822

In this paper, three C ₁₈ columns with different substrates (i.e., porous ACE-3 C ₁₈ , 3μm, fused-core Halo C ₁₈ , 2.7μm, and monolithic Chromolith C ₁₈ ) were compared for the analysis of a pharmaceutical product, Celestoderm-V Ointment ^® , that contains one active pharmaceutical ingredient, betamethasone-17-valerate and one critical pair of low level impurities,...

article

Rapid structure elucidation of drug degradation products using mechanism-based stress studies in conjunction with LC–MSn and NMR spectroscopy: identification of a photodegradation product of betamethasone dipropionate

Mingxiang Lin, Min Li, Alexei V. Buevich, Rebecca Osterman, more

Journal of Pharmaceutical and Biomedical Analysis > 2009 > 50 > 3 > 275-280

Betamethasone dipropionate is an active pharmaceutical ingredient (API) that is used in various dosage forms of finished products for the treatment of inflammatory disorders. An unknown degradant was observed during a solution stability study of betamethasone dipropionate. An approach that combines LC–MS ⁿ , mechanism-based stress studies, semi-preparative HPLC purification and structure elucidation...

article

Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion®

Minshan Shou, Wilmer A. Galinada, Yu-Chien Wei, Qinglin Tang, more

Journal of Pharmaceutical and Biomedical Analysis > 2009 > 50 > 3 > 356-361

Diprosalic Lotion ^® is an anti-inflammatory drug product that contains salicylic acid and betamethasone dipropionate as active pharmaceutical ingredients (APIs). A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneous determination of salicylic acid, betamethasone dipropionate, and their related compounds in Diprosalic Lotion ^® . A 150mm×4...

article

Mechanism of base-catalyzed autooxidation of corticosteroids containing 20-keto-21-hydroxyl side chain

Min Li, Bin Chen, Stephanie Monteiro, Abu M. Rustum

Tetrahedron Letters > 2009 > 50 > 32 > 4575-4581

Corticosteroids and related compounds containing the 20-keto-21-hydroxyl side chain such as betamethasone, betamethasone 9,11-epoxide, dexamethasone, and dexamethasone 9,11-epoxide have been found to undergo facile autooxidation on the 1,3-dihydroxyacetone side chain of their D-rings under strong alkaline conditions to yield five main degradants (17-formyloxy-17-acid, 17-acid, 21-aldehyde, 20-hydroxy-21-acid,...

article

Development and validation of a stability-indicating RP-HPLC method to separate low levels of dexamethasone and other related compounds from betamethasone

Yuan Xiong, Kang Ping Xiao, Abu M. Rustum

Journal of Pharmaceutical and Biomedical Analysis > 2009 > 49 > 3 > 646-654

Betamethasone (BM) is an active pharmaceutical ingredient (API) or an intermediate which is used to manufacture various finished pharmaceutical products. Betamethasone is also used as a starting material to manufacture other APIs that are related to this steroid family. It is quite a challenging task to separate dexamethasone (DM) peak (the alpha epimer) and other structurally related compounds from...

article

Efficient method development strategy for challenging separation of pharmaceutical molecules using advanced chromatographic technologies

Kang Ping Xiao, Yuan Xiong, Fang Zhu Liu, Abu M. Rustum

Journal of Chromatography A > 2007 > 1163 > 1-2 > 145-156

In this paper, we describe a strategy that can be used to efficiently develop a high-performance liquid chromatography (HPLC) separation of challenging pharmaceutical molecules. This strategy involves use of advanced chromatographic technologies, such as a computer-assisted chromatographic method development tool (ChromSword) and an automated column switching system (LC Spiderling). This process significantly...

article

Development and validation of a stability-indicating reversed-phase high performance liquid chromatography method for assay of betamethylepoxide and estimation of its related compounds

Kang Ping Xiao, Dwight Chien, Robert Markovich, Abu M. Rustum

Journal of Chromatography A > 2007 > 1157 > 1-2 > 207-216

Betamethylepoxide (16β-methyl-Δ ^1,4 -pregnadiene-9β-11β-oxide-17α,21-diol-3,20-dione) is a key intermediate for the synthesis of various active pharmaceutical ingredients (APIs) of steroid compounds. A stability-indicating reversed-phase HPLC method for assay of betamethylepoxide and estimation of its related compounds has been developed and validated. This method can accurately quantitate...

article

A Practical Synthesis of the PDE4 Inhibitor, SB-207499, from a Cyclohexanone Precursor

Neil F. Badham, Jian-Hao Chen, Paul G. Cummings, Philip C. Dell'Orco, more

Organic Process Research & Development > 2003 > 7 > 1 > 101 - 108

article

Separation and quantitation of the S-(+)-enantiomer in the bulk drug tiagabine HCl by chiral high-performance-liquid chromatography using a Chiralcel-OD column

Abu M. Rustum, Victoria Estrada

Journal of Chromatography B: Biomedical Sciences and Applications > 1998 > 705 > 1 > 111-117

Tiagabine HCl is being developed as an anti-convulsant/anti-epileptic agent for seizure disorders. The pharmacological activity of the R-(-)-enantiomer is higher than that of the S-(+)-enantiomer. Therefore, the drug is synthesized in the pure R-(-)-enantiomeric form. The enantiomers of tiagabine HCl were separated on a modified cellulose stationary phase (Chiralcel-OD) with a mobile phase of...

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Search results for: Abu M. Rustum

A compatibility study of a secondary amine active pharmaceutical ingredient with starch: Identification of a novel degradant formed between desloratadine and a starch impurity using LC–MSⁿ and NMR spectroscopy

A general static-headspace gas chromatographic method for determination of residual benzene in oral liquid pharmaceutical products

Static headspace gas chromatographic method for the determination of low and high boiling residual solvents in Betamethasone valerate

A stability-indicating reversed-phase high performance liquid chromatography method for simultaneous assay of two corticosteroids and estimation of their related compounds in a pharmaceutical injectable formulation

Thermally induced intramolecular oxygen migration of N‐oxides in atmospheric pressure chemical ionization mass spectrometry

Separation of chiral primary amino compounds by forming a sandwiched complex in reversed-phase high performance liquid chromatography

Development and validation of a stability-indicating RP-HPLC method for assay of betamethasone and estimation of its related compounds

Rapid separation of desloratadine and related compounds in solid pharmaceutical formulation using gradient ion-pair chromatography

A Single RP-LC Method for the Determination of Benzalkonium Chloride and Its Potential Impurities in Benzalkonium Chloride Raw Material

Development of a Stability-Indicating RP-LC Method for Determination of Betamethasone Dipropionate and Estimation of Its Related Compounds in a Dermatological Pharmaceutical Product

Use of high resolution LC–MSn analysis in conjunction with mechanism-based stress studies: Identification of asarinin, an impurity from sesame oil in an animal health product

Comparison study of porous, fused-core, and monolithic silica-based C18 HPLC columns for Celestoderm-V Ointment® analysis

Rapid structure elucidation of drug degradation products using mechanism-based stress studies in conjunction with LC–MSn and NMR spectroscopy: identification of a photodegradation product of betamethasone dipropionate

Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion®

Mechanism of base-catalyzed autooxidation of corticosteroids containing 20-keto-21-hydroxyl side chain

Development and validation of a stability-indicating RP-HPLC method to separate low levels of dexamethasone and other related compounds from betamethasone

Efficient method development strategy for challenging separation of pharmaceutical molecules using advanced chromatographic technologies

Development and validation of a stability-indicating reversed-phase high performance liquid chromatography method for assay of betamethylepoxide and estimation of its related compounds

A Practical Synthesis of the PDE4 Inhibitor, SB-207499, from a Cyclohexanone Precursor

Separation and quantitation of the S-(+)-enantiomer in the bulk drug tiagabine HCl by chiral high-performance-liquid chromatography using a Chiralcel-OD column

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