Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method
A simple, sensitive, specific, precise and accurate stability indicating reverse phase liquid chromatographic method was developed for simultaneous determination of moxifloxacin hydrochloride and dexamethasone in bulk drugs and pharmaceutical formulations. The developed chromatographic method was op...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2017-03-01
|
| Series: | Arabian Journal of Chemistry |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1878535214002640 |
| _version_ | 1811263591431536640 |
|---|---|
| author | Syed Naeem Razzaq Muhammad Ashfaq Islam Ullah Khan Irfana Mariam Syed Saleem Razzaq Waqar Azeem |
| author_facet | Syed Naeem Razzaq Muhammad Ashfaq Islam Ullah Khan Irfana Mariam Syed Saleem Razzaq Waqar Azeem |
| author_sort | Syed Naeem Razzaq |
| collection | DOAJ |
| description | A simple, sensitive, specific, precise and accurate stability indicating reverse phase liquid chromatographic method was developed for simultaneous determination of moxifloxacin hydrochloride and dexamethasone in bulk drugs and pharmaceutical formulations. The developed chromatographic method was optimized for the separations of moxifloxacin hydrochloride, dexamethasone and stress-induced degradation products by the use of BDS Hypersil C8 column (250 × 4.6 mm, 5 μm) as stationary phase with mobile phase consisting of a mixture of phosphate buffer (20 mM) containing 0.1% (v/v) triethylamine, at pH 2.8 (adjusted with dilute phosphoric acid) and methanol (38.5:61.5 v/v) at a flow rate of 1.5 mL min−1. Chromatographic separations of analytical peaks and degradation products were achieved within 10 min. Detection of the analytes and degradation products was performed at 254 nm using a diode array detector. Method validation was performed in accordance with ICH guidelines. Linearity of the method was established over the concentration ranges of 50–350 μg mL−1 for moxifloxacin hydrochloride and 10–70 μg mL−1 for dexamethasone (correlation coefficients greater than 0.999). The method resulted in good separation of both the analytes and degradation products with acceptable tailing and resolution with peak purity index ⩾0.9999 which indicated complete separation of analyte peaks from the degradation products. The method can therefore be considered as stability-indicating and can be used successfully for simultaneous determination of moxifloxacin hydrochloride and dexamethasone in pharmaceutical formulations and stability studies. |
| first_indexed | 2024-04-12T19:48:07Z |
| format | Article |
| id | doaj.art-e2b0cd23b9394637b30abd8602f2f859 |
| institution | Directory Open Access Journal |
| issn | 1878-5352 |
| language | English |
| last_indexed | 2024-04-12T19:48:07Z |
| publishDate | 2017-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Arabian Journal of Chemistry |
| spelling | doaj.art-e2b0cd23b9394637b30abd8602f2f8592022-12-22T03:18:54ZengElsevierArabian Journal of Chemistry1878-53522017-03-0110332132810.1016/j.arabjc.2014.11.016Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC methodSyed Naeem Razzaq0Muhammad Ashfaq1Islam Ullah Khan2Irfana Mariam3Syed Saleem Razzaq4Waqar Azeem5Department of Chemistry, Government College University, Lahore 54000, PakistanDepartment of Chemistry, University of Gujrat, H.H. Campus, Gujrat 50700, PakistanDepartment of Chemistry, Government College University, Lahore 54000, PakistanDepartment of Chemistry, Queen Marry College, Lahore 54000, PakistanMedipharm Pharmaceuticals Kot Lakhpat, Lahore 54000, PakistanDepartment of Chemistry, Government College University, Lahore 54000, PakistanA simple, sensitive, specific, precise and accurate stability indicating reverse phase liquid chromatographic method was developed for simultaneous determination of moxifloxacin hydrochloride and dexamethasone in bulk drugs and pharmaceutical formulations. The developed chromatographic method was optimized for the separations of moxifloxacin hydrochloride, dexamethasone and stress-induced degradation products by the use of BDS Hypersil C8 column (250 × 4.6 mm, 5 μm) as stationary phase with mobile phase consisting of a mixture of phosphate buffer (20 mM) containing 0.1% (v/v) triethylamine, at pH 2.8 (adjusted with dilute phosphoric acid) and methanol (38.5:61.5 v/v) at a flow rate of 1.5 mL min−1. Chromatographic separations of analytical peaks and degradation products were achieved within 10 min. Detection of the analytes and degradation products was performed at 254 nm using a diode array detector. Method validation was performed in accordance with ICH guidelines. Linearity of the method was established over the concentration ranges of 50–350 μg mL−1 for moxifloxacin hydrochloride and 10–70 μg mL−1 for dexamethasone (correlation coefficients greater than 0.999). The method resulted in good separation of both the analytes and degradation products with acceptable tailing and resolution with peak purity index ⩾0.9999 which indicated complete separation of analyte peaks from the degradation products. The method can therefore be considered as stability-indicating and can be used successfully for simultaneous determination of moxifloxacin hydrochloride and dexamethasone in pharmaceutical formulations and stability studies.http://www.sciencedirect.com/science/article/pii/S1878535214002640Reverse phase liquid chromatographyMoxifloxacinDexamethasoneStress induced degradation productsICH guidelines |
| spellingShingle | Syed Naeem Razzaq Muhammad Ashfaq Islam Ullah Khan Irfana Mariam Syed Saleem Razzaq Waqar Azeem Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method Arabian Journal of Chemistry Reverse phase liquid chromatography Moxifloxacin Dexamethasone Stress induced degradation products ICH guidelines |
| title | Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method |
| title_full | Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method |
| title_fullStr | Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method |
| title_full_unstemmed | Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method |
| title_short | Simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating HPLC method |
| title_sort | simultaneous determination of dexamethasone and moxifloxacin in pharmaceutical formulations using stability indicating hplc method |
| topic | Reverse phase liquid chromatography Moxifloxacin Dexamethasone Stress induced degradation products ICH guidelines |
| url | http://www.sciencedirect.com/science/article/pii/S1878535214002640 |
| work_keys_str_mv | AT syednaeemrazzaq simultaneousdeterminationofdexamethasoneandmoxifloxacininpharmaceuticalformulationsusingstabilityindicatinghplcmethod AT muhammadashfaq simultaneousdeterminationofdexamethasoneandmoxifloxacininpharmaceuticalformulationsusingstabilityindicatinghplcmethod AT islamullahkhan simultaneousdeterminationofdexamethasoneandmoxifloxacininpharmaceuticalformulationsusingstabilityindicatinghplcmethod AT irfanamariam simultaneousdeterminationofdexamethasoneandmoxifloxacininpharmaceuticalformulationsusingstabilityindicatinghplcmethod AT syedsaleemrazzaq simultaneousdeterminationofdexamethasoneandmoxifloxacininpharmaceuticalformulationsusingstabilityindicatinghplcmethod AT waqarazeem simultaneousdeterminationofdexamethasoneandmoxifloxacininpharmaceuticalformulationsusingstabilityindicatinghplcmethod |