Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation
A new specific, precise, accurate, and robust TLC-densitometry has been developed for the simultaneous determination of hydrocortisone acetate and lidocaine hydrochloride in combined pharmaceutical formulation. The chromatographic analysis was carried out using a mobile phase consisting of chlorofor...
Saved in:
| Main Authors: | , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2014-01-01
|
| Series: | The Scientific World Journal |
| Online Access: | http://dx.doi.org/10.1155/2014/107879 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850214500157882368 |
|---|---|
| author | Małgorzata Dołowy Katarzyna Kulpińska-Kucia Alina Pyka |
| author_facet | Małgorzata Dołowy Katarzyna Kulpińska-Kucia Alina Pyka |
| author_sort | Małgorzata Dołowy |
| collection | DOAJ |
| description | A new specific, precise, accurate, and robust TLC-densitometry has been developed for the simultaneous determination of hydrocortisone acetate and lidocaine hydrochloride in combined pharmaceutical formulation. The chromatographic analysis was carried out using a mobile phase consisting of chloroform + acetone + ammonia (25%) in volume composition 8 : 2 : 0.1 and silica gel 60F254 plates. Densitometric detection was performed in UV at wavelengths 200 nm and 250 nm, respectively, for lidocaine hydrochloride and hydrocortisone acetate. The validation of the proposed method was performed in terms of specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, and robustness. The applied TLC procedure is linear in hydrocortisone acetate concentration range of 3.75÷12.50 μg·spot−1, and from 1.00÷2.50 μg·spot−1 for lidocaine hydrochloride. The developed method was found to be accurate (the value of the coefficient of variation CV [%] is less than 3%), precise (CV [%] is less than 2%), specific, and robust. LOQ of hydrocortisone acetate is 0.198 μg·spot−1 and LOD is 0.066 μg·spot−1. LOQ and LOD values for lidocaine hydrochloride are 0.270 and 0.090 μg·spot−1, respectively. The assay value of both bioactive substances is consistent with the limits recommended by Pharmacopoeia. |
| format | Article |
| id | doaj-art-810bde5d4e85427c9cb4fc97feb30aef |
| institution | OA Journals |
| issn | 2356-6140 1537-744X |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Scientific World Journal |
| spelling | doaj-art-810bde5d4e85427c9cb4fc97feb30aef2025-08-20T02:08:53ZengWileyThe Scientific World Journal2356-61401537-744X2014-01-01201410.1155/2014/107879107879Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical PreparationMałgorzata Dołowy0Katarzyna Kulpińska-Kucia1Alina Pyka2Department of Analytical Chemistry, Faculty of Pharmacy, Medical University of Silesia, PL-4 Jagiellońska Street, 41-200 Sosnowiec, PolandDepartment of Analytical Chemistry, Faculty of Pharmacy, Medical University of Silesia, PL-4 Jagiellońska Street, 41-200 Sosnowiec, PolandDepartment of Analytical Chemistry, Faculty of Pharmacy, Medical University of Silesia, PL-4 Jagiellońska Street, 41-200 Sosnowiec, PolandA new specific, precise, accurate, and robust TLC-densitometry has been developed for the simultaneous determination of hydrocortisone acetate and lidocaine hydrochloride in combined pharmaceutical formulation. The chromatographic analysis was carried out using a mobile phase consisting of chloroform + acetone + ammonia (25%) in volume composition 8 : 2 : 0.1 and silica gel 60F254 plates. Densitometric detection was performed in UV at wavelengths 200 nm and 250 nm, respectively, for lidocaine hydrochloride and hydrocortisone acetate. The validation of the proposed method was performed in terms of specificity, linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, and robustness. The applied TLC procedure is linear in hydrocortisone acetate concentration range of 3.75÷12.50 μg·spot−1, and from 1.00÷2.50 μg·spot−1 for lidocaine hydrochloride. The developed method was found to be accurate (the value of the coefficient of variation CV [%] is less than 3%), precise (CV [%] is less than 2%), specific, and robust. LOQ of hydrocortisone acetate is 0.198 μg·spot−1 and LOD is 0.066 μg·spot−1. LOQ and LOD values for lidocaine hydrochloride are 0.270 and 0.090 μg·spot−1, respectively. The assay value of both bioactive substances is consistent with the limits recommended by Pharmacopoeia.http://dx.doi.org/10.1155/2014/107879 |
| spellingShingle | Małgorzata Dołowy Katarzyna Kulpińska-Kucia Alina Pyka Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation The Scientific World Journal |
| title | Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation |
| title_full | Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation |
| title_fullStr | Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation |
| title_full_unstemmed | Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation |
| title_short | Validation of a Thin-Layer Chromatography for the Determination of Hydrocortisone Acetate and Lidocaine in a Pharmaceutical Preparation |
| title_sort | validation of a thin layer chromatography for the determination of hydrocortisone acetate and lidocaine in a pharmaceutical preparation |
| url | http://dx.doi.org/10.1155/2014/107879 |
| work_keys_str_mv | AT małgorzatadołowy validationofathinlayerchromatographyforthedeterminationofhydrocortisoneacetateandlidocaineinapharmaceuticalpreparation AT katarzynakulpinskakucia validationofathinlayerchromatographyforthedeterminationofhydrocortisoneacetateandlidocaineinapharmaceuticalpreparation AT alinapyka validationofathinlayerchromatographyforthedeterminationofhydrocortisoneacetateandlidocaineinapharmaceuticalpreparation |