Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form
A binary mixture of almitrine besmesylate (A) and raubasine (R) was determined by two different chromatographic methods. The first method was based on HPTLC separation of the two drugs followed by densitometric measurement of their spots at 245 and 285 nm for A and R, respectively. The separation wa...
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Faculty of Pharmacy, Cairo University
2013-06-01
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| Series: | Bulletin of Faculty of Pharmacy Cairo University |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1110093113000033 |
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| author | Mai A. Basha Kareem M. Younes Hanaa K. Mickael Faten A. El Aziz Maissa Y. Salem |
| author_facet | Mai A. Basha Kareem M. Younes Hanaa K. Mickael Faten A. El Aziz Maissa Y. Salem |
| author_sort | Mai A. Basha |
| collection | DOAJ |
| description | A binary mixture of almitrine besmesylate (A) and raubasine (R) was determined by two different chromatographic methods. The first method was based on HPTLC separation of the two drugs followed by densitometric measurement of their spots at 245 and 285 nm for A and R, respectively. The separation was carried out using HPTLC silica gel F254 nanoplates with methanol:ammonia (10:8, v/v) as developing solvent. The linearity was achieved over concentration range of 0.5–8 μg/spot and 0.5–10 μg/spot with mean accuracy 100.79 ± 1.58 and 100.68 ± 1.78, for A and R, respectively. The second method involved the determination of A and R using reversed phase high performance liquid chromatography (HPLC) on C18 column using acetonitrile:potassium dihydrogen orthophosphate buffer pH = 4.7 (70:30, v/v) as mobile phase with flow rate at 2 ml/min. Quantitation was achieved using UV detection at 220 nm. A linear relationship was obtained over a concentration range of 0.75–105 μg ml−1 for both drugs with mean accuracy 100.85 ± 1.74 and 98.82 ± 1.31, for A and R, respectively. The methods were successfully applied for the determination of the cited drugs in dosage forms. The proposed methods were validated according to USP and were found to be valid and suitable for the assay of the cited drugs in dosage forms in quality control laboratories. |
| first_indexed | 2024-04-11T03:12:42Z |
| format | Article |
| id | doaj.art-64fbba078c1142269d4b7736298ffbda |
| institution | Directory Open Access Journal |
| issn | 1110-0931 |
| language | English |
| last_indexed | 2024-04-11T03:12:42Z |
| publishDate | 2013-06-01 |
| publisher | Faculty of Pharmacy, Cairo University |
| record_format | Article |
| series | Bulletin of Faculty of Pharmacy Cairo University |
| spelling | doaj.art-64fbba078c1142269d4b7736298ffbda2023-01-02T11:14:12ZengFaculty of Pharmacy, Cairo UniversityBulletin of Faculty of Pharmacy Cairo University1110-09312013-06-01511899410.1016/j.bfopcu.2013.02.001Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage formMai A. Basha0Kareem M. Younes1Hanaa K. Mickael2Faten A. El Aziz3Maissa Y. Salem4National Organization of Drug Control and Research (NODCAR), Cairo, EgyptAnalytical Chemistry Department, Faculty of Pharmacy, Cairo University, EgyptNational Organization of Drug Control and Research (NODCAR), Cairo, EgyptEgyptian National Regulatory Authority (ENRA), Cairo, EgyptAnalytical Chemistry Department, Faculty of Pharmacy, Cairo University, EgyptA binary mixture of almitrine besmesylate (A) and raubasine (R) was determined by two different chromatographic methods. The first method was based on HPTLC separation of the two drugs followed by densitometric measurement of their spots at 245 and 285 nm for A and R, respectively. The separation was carried out using HPTLC silica gel F254 nanoplates with methanol:ammonia (10:8, v/v) as developing solvent. The linearity was achieved over concentration range of 0.5–8 μg/spot and 0.5–10 μg/spot with mean accuracy 100.79 ± 1.58 and 100.68 ± 1.78, for A and R, respectively. The second method involved the determination of A and R using reversed phase high performance liquid chromatography (HPLC) on C18 column using acetonitrile:potassium dihydrogen orthophosphate buffer pH = 4.7 (70:30, v/v) as mobile phase with flow rate at 2 ml/min. Quantitation was achieved using UV detection at 220 nm. A linear relationship was obtained over a concentration range of 0.75–105 μg ml−1 for both drugs with mean accuracy 100.85 ± 1.74 and 98.82 ± 1.31, for A and R, respectively. The methods were successfully applied for the determination of the cited drugs in dosage forms. The proposed methods were validated according to USP and were found to be valid and suitable for the assay of the cited drugs in dosage forms in quality control laboratories.http://www.sciencedirect.com/science/article/pii/S1110093113000033Almitrine besmesylateRaubasineHPTLCHPLC |
| spellingShingle | Mai A. Basha Kareem M. Younes Hanaa K. Mickael Faten A. El Aziz Maissa Y. Salem Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form Bulletin of Faculty of Pharmacy Cairo University Almitrine besmesylate Raubasine HPTLC HPLC |
| title | Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form |
| title_full | Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form |
| title_fullStr | Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form |
| title_full_unstemmed | Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form |
| title_short | Development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form |
| title_sort | development and validation of two chromatographic methods for the simultaneous determination of raubasine and almitrine besmesylate in pharmaceutical dosage form |
| topic | Almitrine besmesylate Raubasine HPTLC HPLC |
| url | http://www.sciencedirect.com/science/article/pii/S1110093113000033 |
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