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 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 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 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 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 Method for Selegiline Hydrochloride and Related Compounds in Raw Materials and Tablets

1991 ◽  
Vol 74 (3) ◽  
pp. 453-455
Author(s):  
Normand Beaulieu ◽  
Terry D Cyr ◽  
Susan J Graham ◽  
Edward G Lovering
Keyword(s):  
Chromatographic Method ◽  
Raw Materials ◽  
Infrared Detector ◽  
Raw Material ◽  
Related Substances ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic method has been developed for determination of selegiline hydrochloride and related substances in drug raw material and tablet formulations. The method resolves 3 known related compounds from the drug with a limit of quantitation of less than 0.05%. Drug raw material and tablet samples contained ca 0.2 and 0.6% impurities, respectively. These included some related compounds, the identities of which were confirmed by gas chromatography with a Fourier transform Infrared detector.

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 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 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.

Determination of Diclofenac Sodium and Related Compounds in Raw Materials and Formulations

1990 ◽  
Vol 73 (5) ◽  
pp. 698-701 ◽  
Author(s):  
Normand Beaulieu ◽  
Edward G Lovering ◽  
Johanne Lefrancois ◽  
H Ong
Keyword(s):  
Raw Materials ◽  
Diclofenac Sodium ◽  
Raw Material ◽  
Liquid Chromatographic Method ◽  
Bonded Phase ◽  
Total Impurity ◽  
Enteric Coated ◽  
Liquid Chromatographic ◽  
Related Compounds

Abstract A liquid chromatographic method has been developed for determination of drug and related compounds In diclofenac sodium raw material, slow-release, and enteric coated tablets. The method specifies a 5μm octadecylsllane bonded phase column, a mobile phase of tetrahydrofuran-acetonltrlle- buffer, pH 5 (1 + 4 + 8.3), and detection at 229 nm. The method resolves 10 known related compounds with limits of quantitation of 0.2% or less. Seventeen drug raw material samples were evaluated. Total Impurity levels ranged from 0.1 to 0.9%. The method has also been used for determination of drug content In raw materials and formulations. Mean assay levels In drug raw materials ranged between 98.3% and 101.8%.

Liquid Chromatographic Determination of Nifursol in Concentrates, Premixes, and Finished Turkey Feeds

1994 ◽  
Vol 77 (6) ◽  
pp. 1347-1352
Author(s):  
Ellen Jan De Vries ◽  
Richard C Bas ◽  
Henny Kuil
Keyword(s):  
Chromatographic Determination ◽  
Test Sample ◽  
Liquid Chromatographic Method ◽  
Limit Of Quantitation ◽  
Order Of Magnitude ◽  
Pelleted Feed ◽  
Liquid Chromatographic Determination ◽  
Liquid Chromatographic ◽  
Better Than

Abstract A specific liquid chromatographic method was developed for determination of nifursol in premixes and turkey feeds. Nifursol is extracted from test sample into tetrahydrofuran. Butylhydroxytoluene is added to prevent degradation of nifursol. The extract is diluted with tetrahydrofuran–water (50 + 50, v/v); an aliquot is injected onto a Zorbax ODS column. The mobile phase is water-acetonitrile (525 + 475, v/v) adjusted to an apparent pH of 3.5 with formic acid and ammonia. The wavelength of detection is 380 nm. The system can separate nifursol from dimetridazole and ronidazole. The method is specific; has linearity of more than one order of magnitude; and has a limit of quantitation in the 1–2 ppm range. Recovery averaged 98% or more, and the reproducibility had a coefficient of variation of better than 2.5% in pelleted feed.

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