Liquid Chromatographic Determination of Cromolyn Sodium and Related Compounds in Raw Materials

1994 ◽  
Vol 77 (6) ◽  
pp. 1439-1442 ◽  
Author(s):  
Randy M Duhaime ◽  
Lorna K Rollins ◽  
Dennis J K Gorecki ◽  
Edward G Lovering
Keyword(s):  
Mobile Phase ◽  
Raw Materials ◽  
Chromatographic Determination ◽  
Cromolyn Sodium ◽  
Raw Material ◽  
Assay Method ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract Liquid chromatographic methods for the assay of cromolyn sodium and 3 related compounds were developed. The methods, which differ only in the composition of the mobile phase, use an octadecylsilane bonded-phase column and an acetonitrile–water–cetyltrimethylammonium bromide mobile phase. Minimum quantitatable amounts of the related compounds were less than 0.05%; assay method precision was better than 1 %. Impurity levels in raw material samples from 4 manufacturers were less than 0.1 %.

Liquid Chromatographic Determination of Naproxen and Related Compounds in Raw Materials

1990 ◽  
Vol 73 (6) ◽  
pp. 902-904 ◽  
Author(s):  
David B Moir ◽  
Normand Beaulieu ◽  
Norman M Curran ◽  
Edward G Lovering
Keyword(s):  
Acetic Acid ◽  
Mobile Phase ◽  
Raw Materials ◽  
Chromatographic Determination ◽  
Assay Method ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic (LC) method for determination of naproxen and 8 known related compounds has been developed. The lower limit of quantitation of the related compounds In the drug Is 0.04% or less for all compounds; the precision of the drug assay method Is ca 0.4%. The method uses an octadecylsllyl column, a mobile phase of 1 % acetic acid (v/v)-methanol-acetonitrlle (48 + 22 + 30, v/v/v) and detection at 231 nm.

Liquid Chromatographic Determination of Alprazolam and Related Impurities in the Drug Substance

1992 ◽  
Vol 75 (5) ◽  
pp. 801-803 ◽  
Author(s):  
Normand Beaulieu ◽  
Susan J Graham ◽  
Roger W Sears ◽  
Edward G Lovering
Keyword(s):  
Mobile Phase ◽  
Raw Materials ◽  
Chromatographic Determination ◽  
Raw Material ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic method was developed for the determination of alprazolam and 5 known related compounds in drug raw materials. The method is based on a 3 µm cyano column (100 x 4.6 mm), a mobile phase of 0.01% phosphoric acidacetonitrile- methanol (6 + 3 +1), a flow rate of 1.5 mL/min, and detection at 230 nm. The method resolves the related compounds from the drug and from each other. The limit of quantitation for the impurities in drug raw material is less than 0.1%. Impurity levels in 4 drug raw materials were between 0.01 and 0.41 %. The corresponding mean assay values ranged from 98.3 to 100.6%.

Liquid Chromatographic Determination of Amiodarone Hydrochloride and Related Compounds in Raw Materials and Tablets

1994 ◽  
Vol 77 (6) ◽  
pp. 1447-1453 ◽  
Author(s):  
Pauline M Lacrok ◽  
Norman M Curran ◽  
Wing-Wah Sy ◽  
Dennis K J Goreck ◽  
Pierre Thibault ◽  
...  
Keyword(s):  
Raw Materials ◽  
Chromatographic Determination ◽  
Raw Material ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Amiodarone Hydrochloride ◽  
Related Compounds

Abstract A liquid chromatographic method for the determination of amiodarone hydrochloride and 10 related compounds in drug raw material and for assay of drug in tablets was developed. The method specifies a 3 jxm Hypersil nitrile column (150 × 4.6 mm), a mobile phase of 1 + 1 acetonitrile–ammonium acetate buffer (0.1 M adjusted to pH 6.0 with 0.1 M acetic acid), a flow rate of 1 mL/min, and detection at 240 nm. The lower limit of quantitation of the related compounds is 0.02% or less. Drug contents in 2 raw material samples were 100.1 and 99.9% and ranged from 98.2 to 99.4% in 3 tablet formulations. Impurity levels in 2 samples of raw material from different manufacturers were ca 0.4%. The presence of 3 of the known related compounds in these samples was confirmed by liquid chromatographymass spectrometry. The method applied to raw materials was evaluated by a second laboratory and found to be satisfactory.

Liquid Chromatographic Determination of Glyburide (Glibenclamide) and Its Related Compounds in Raw Materials

1993 ◽  
Vol 76 (5) ◽  
pp. 962-965
Author(s):  
Normand Beaulieu ◽  
Susan J Graham ◽  
Edward G Lovering
Keyword(s):  
Raw Materials ◽  
Chromatographic Determination ◽  
Assay Method ◽  
Liquid Chromatographic Method ◽  
Relative Standard ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic method has been developed for the determination of glyburide and 3 known related compounds in drug raw materials. The lower limit of quantitation of the related compounds is about 0.02%. Evaluation of 9 drug raw materials revealed total impurities ranging from 0.17 to 0.65%. The relative standard deviation of the assay method is <1%.

Liquid Chromatographic Determination of Tolrestat and Related Compounds in Raw Materials

1995 ◽  
Vol 78 (3) ◽  
pp. 647-650 ◽  
Author(s):  
Normand Beaulieu ◽  
Pauline M Lacrok ◽  
Roger W Sears ◽  
Edward G Loveremg
Keyword(s):  
Raw Materials ◽  
Chromatographic Determination ◽  
Raw Material ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Related Compounds ◽  
Different Sources

Abstract A liquid chromatographic method was developed for the determination of tolrestat and 7 related compounds. The lower limit of quantitation of the related compounds in the presence of the drug was <0.05%. The coefficient of variation on the assay of drug raw material analyzed on 5 different days was 0.75%. Total impurities found in 2 samples of tolrestat from different sources were 0.12 and 0.54%, respectively. The method was validated by a second laboratory.

Liquid Chromatographic Determination of Ketoprofen and Its Related Compounds in Raw Materials, Capsules, and Enteric Coated Tablets

1989 ◽  
Vol 72 (4) ◽  
pp. 559-561
Author(s):  
Beaulieu Beaulieu ◽  
J Lefrancois ◽  
H Ong ◽  
Edward G Lovering
Keyword(s):  
Raw Materials ◽  
Chromatographic Determination ◽  
Raw Material ◽  
Oral Dosage ◽  
Assay Method ◽  
Limit Of Quantitation ◽  
Enteric Coated ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic method for the determination of ketoprofen and 6 known related compounds has been developed. The lower limit of quantitation of the related compounds in the drug is 0.05% or less for all compounds, and the precision of the drug assay method is about 1.5%. The highest levels of impurities found in 3 drug raw material samples and 4 solid oral dosage formulations were 1.37 and 0.43%, respectively.

Liquid Chromatographic Determination of Pindolol and Related Compounds in Raw Materials

1990 ◽  
Vol 73 (4) ◽  
pp. 521-525
Author(s):  
P M Lacroix ◽  
D Moir ◽  
E G Lovering
Keyword(s):  
Raw Materials ◽  
Chromatographic Determination ◽  
Raw Material ◽  
Uv Detector ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic Determination ◽  
Bulk Drug ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic method for the assay of pindolol and related compounds In the bulk drug has been developed. The method resolves 6 known and several unknown impurities from the drug and each other by using a nitrile column, an acetonitrlle-sodlum acetate buffer (35 + 65), and a UV detector set at 219 nm. Minimum quantifiable amounts of Impurities are 0.02% or less relative to the drug. Ten lots of pindolol raw material were evaluated for purity and drug content. Total levels of Impurities In these samples, quantltated against pindolol, ranged from about 0.03 to 0.24%. Assay results were within the range of 98.5 to 101.5%.

Liquid Chromatographic Determination of Sodium Salinomycin in Feeds, with Post-Column Reaction

1984 ◽  
Vol 67 (4) ◽  
pp. 701-706 ◽  
Author(s):  
John T Goras ◽  
William R Lacourse
Keyword(s):  
Mobile Phase ◽  
Reaction System ◽  
Chromatographic Determination ◽  
Average Recovery ◽  
Commercial Scale ◽  
Liquid Chromatographic Determination ◽  
Effluent Stream ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A method for the detection and quantitation of sodium salinomycin in feeds by a liquid chromatographic, post-column reaction system is presented. Sodium salinomycin is leached from feed with hexane, isolated as a dried residue, and dissolved in mobile phase for analysis. The drug is separated from interfering substances on a silica LC column, combined with vanillin reagent in a mixing tee, reacted with vanillin at elevated temperature in a coil, and detected in the effluent stream at 527 nm. Response, as peak area, is linear with concentration. Feed components, other common veterinary drugs, and closely related compounds do not interfere. Average recovery and coefficient of variation (CV) values for liquid spiked feeds and supplements were 101 ± 3.5% and 100 ± 0.3%, respectively. Results for laboratory blends and commercial scale feeds were within 6% of intent with CV values ranging from 0.4 to 5.1%.

scholarly journals Liquid Chromatographic Determination of Thalidomide in Tablets, Capsules, and Raw Materials

1997 ◽  
Vol 80 (4) ◽  
pp. 767-774 ◽  
Author(s):  
John C Reepmeyer ◽  
Don C Cox
Keyword(s):  
Raw Materials ◽  
Internal Standard ◽  
Chromatographic Determination ◽  
Assay Method ◽  
Content Uniformity ◽  
Liquid Chromatographic Method ◽  
Bonded Phase ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic

Abstract A simple, isocratic liquid chromatographic method for assay of thalidomide in tablets, capsules, and raw materials was developed. The method uses a Nova-Pak octadecylsilane bonded-phase column (150 × 3.9 mm, 4 μm particle size), a mobile phase of acetonitrile-water (15 + 85), a flow rate of 1 mL/min, detection at 237 nm, and phenacetin as internal standard. Phosphoric acid was used in preparation of sample solutions to inhibit thalidomide hydrolysis. Assays ranged from 99.3 to 100.4% in raw materials from 4 manufacturers, from 79.7 to 104.8% in tablets from 7 manufacturers, and from 75.3 to 102.6% in capsules from 4 manufacturers. Assay method precisions for triplicate analyses on 5 days were 0.30% for tablets, 0.22% for capsules, and 0.22% for raw materials. Recovery from simulated tablet formulations was 100%. The method has been used to analyze individual tablets and capsules for determination of content uniformity.

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