Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation
In the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250–...
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| Format: | Article |
| Language: | English |
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Wiley
2013-01-01
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| Series: | The Scientific World Journal |
| Online Access: | http://dx.doi.org/10.1155/2013/564962 |
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| author | Stanislaw Han Katarzyna Karlowicz-Bodalska Dorota Szura Lukasz Ozimek Witold Musial |
| author_facet | Stanislaw Han Katarzyna Karlowicz-Bodalska Dorota Szura Lukasz Ozimek Witold Musial |
| author_sort | Stanislaw Han |
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| description | In the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250–4 mm (5 μm) was used in the assay, and the mobile phase gradient consisted of three phases: A—methanol : water (5 : 95) + 1.5% (v/v) acetic acid; B—water : methanol (5 : 95) + 1.5% (v/v) acetic acid; and C—chloroform. Detection of the impurities and the active substance was performed by an evaporative light-scattering detector. The method was validated for selectivity, system precision, method precision, limit of detection, and response rates. The proposed method can be used to detect impurities in the liposomal formulation of azelaic acid. The method enables separation of azelaic acid from the identified and unidentified impurities and from the excipients used in the drug form. |
| format | Article |
| id | doaj-art-8661168d98ae491d929191cf9637d843 |
| institution | Kabale University |
| issn | 1537-744X |
| language | English |
| publishDate | 2013-01-01 |
| publisher | Wiley |
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| series | The Scientific World Journal |
| spelling | doaj-art-8661168d98ae491d929191cf9637d8432025-02-03T06:14:08ZengWileyThe Scientific World Journal1537-744X2013-01-01201310.1155/2013/564962564962Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal FormulationStanislaw Han0Katarzyna Karlowicz-Bodalska1Dorota Szura2Lukasz Ozimek3Witold Musial4Department of Industrial Pharmacy, Wroclaw Medical University, Borowska Street 211A, 50-556 Wroclaw, PolandDepartment of Industrial Pharmacy, Wroclaw Medical University, Borowska Street 211A, 50-556 Wroclaw, PolandResearch and Development Center NOVASOME, Olsztyńska Street 5, 51-423 Wroclaw, PolandResearch and Development Center NOVASOME, Olsztyńska Street 5, 51-423 Wroclaw, PolandDepartment of Physical Chemistry, Wroclaw Medical University, Borowska Street 211A, 50-556 Wroclaw, PolandIn the course of research and development of a new pharmaceutical formulation of azelaic acid in the liposomal form, we developed a rapid and accurate method for the detection of impurities using high-performance liquid chromatography. A chromatographic column from Merck (Purospher Star RP C18, 250–4 mm (5 μm) was used in the assay, and the mobile phase gradient consisted of three phases: A—methanol : water (5 : 95) + 1.5% (v/v) acetic acid; B—water : methanol (5 : 95) + 1.5% (v/v) acetic acid; and C—chloroform. Detection of the impurities and the active substance was performed by an evaporative light-scattering detector. The method was validated for selectivity, system precision, method precision, limit of detection, and response rates. The proposed method can be used to detect impurities in the liposomal formulation of azelaic acid. The method enables separation of azelaic acid from the identified and unidentified impurities and from the excipients used in the drug form.http://dx.doi.org/10.1155/2013/564962 |
| spellingShingle | Stanislaw Han Katarzyna Karlowicz-Bodalska Dorota Szura Lukasz Ozimek Witold Musial Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation The Scientific World Journal |
| title | Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation |
| title_full | Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation |
| title_fullStr | Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation |
| title_full_unstemmed | Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation |
| title_short | Application of HPLC with ELSD Detection for the Assessment of Azelaic Acid Impurities in Liposomal Formulation |
| title_sort | application of hplc with elsd detection for the assessment of azelaic acid impurities in liposomal formulation |
| url | http://dx.doi.org/10.1155/2013/564962 |
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