Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)
CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The...
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| Format: | Article |
| Language: | English |
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Elsevier
2013-10-01
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| Series: | Journal of Pharmaceutical Analysis |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2095177913000397 |
| _version_ | 1819294966566879232 |
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| author | Kiran Khandelwal Shakti Deep Pachauri Sofia Zaidi Pankaj Dwivedi Ashok Kumar Sharma Chandan Singh Anil Kumar Dwivedi |
| author_facet | Kiran Khandelwal Shakti Deep Pachauri Sofia Zaidi Pankaj Dwivedi Ashok Kumar Sharma Chandan Singh Anil Kumar Dwivedi |
| author_sort | Kiran Khandelwal |
| collection | DOAJ |
| description | CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LLOQ) were determined according to International Conference on Harmonization ICH Q2(R1) guidelines. HPLC separation was achieved on a RP-select B Lichrosphere® column (250 mmÃ4 mm, 5 μm, Merck) using water containing 0.1% glacial acetic acid and acetonitrile as the mobile phase in a gradient elution. The eluents were monitored by a photo diode array detector at 245 and 275 nm. Based on signal to noise ratio of 3 and 10 the LOD of CDRI 99/411 was 0.55 µg/mL, while the LLOQ was 1.05 µg/mL. The calibration curves were linear in the range of 1.05â68 µg/mL. Precision of the method was determined by inter- and intra-assay variations within the acceptable range. Keywords: HPLC, Trioxane, Process quality control, Stability |
| first_indexed | 2024-12-24T04:34:43Z |
| format | Article |
| id | doaj.art-f9122fe64f184697a9c12153aa3f6ec2 |
| institution | Directory Open Access Journal |
| issn | 2095-1779 |
| language | English |
| last_indexed | 2024-12-24T04:34:43Z |
| publishDate | 2013-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Pharmaceutical Analysis |
| spelling | doaj.art-f9122fe64f184697a9c12153aa3f6ec22022-12-21T17:15:16ZengElsevierJournal of Pharmaceutical Analysis2095-17792013-10-0135335340Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411)Kiran Khandelwal0Shakti Deep Pachauri1Sofia Zaidi2Pankaj Dwivedi3Ashok Kumar Sharma4Chandan Singh5Anil Kumar Dwivedi6Division of Pharmaceutics, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, IndiaDivision of Pharmaceutics, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, IndiaDivision of Pharmaceutics, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, IndiaDivision of Pharmaceutics, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, IndiaDivision of Medicinal and Process Chemistry, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, IndiaDivision of Medicinal and Process Chemistry, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, IndiaDivision of Pharmaceutics, CSIR-Central Drug Research Institute, Chattar Manzil Palace, Lucknow 226001, India; Corresponding author at: Pharmaceutics Division, CSIR-Central Drug Research Institute, Post Box No.173, MG Road, Lucknow 226001, India.Tel.: +91 522 2623405; fax: +91 522 2623938.CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and lower limit of quantification (LLOQ) were determined according to International Conference on Harmonization ICH Q2(R1) guidelines. HPLC separation was achieved on a RP-select B Lichrosphere® column (250 mmÃ4 mm, 5 μm, Merck) using water containing 0.1% glacial acetic acid and acetonitrile as the mobile phase in a gradient elution. The eluents were monitored by a photo diode array detector at 245 and 275 nm. Based on signal to noise ratio of 3 and 10 the LOD of CDRI 99/411 was 0.55 µg/mL, while the LLOQ was 1.05 µg/mL. The calibration curves were linear in the range of 1.05â68 µg/mL. Precision of the method was determined by inter- and intra-assay variations within the acceptable range. Keywords: HPLC, Trioxane, Process quality control, Stabilityhttp://www.sciencedirect.com/science/article/pii/S2095177913000397 |
| spellingShingle | Kiran Khandelwal Shakti Deep Pachauri Sofia Zaidi Pankaj Dwivedi Ashok Kumar Sharma Chandan Singh Anil Kumar Dwivedi Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411) Journal of Pharmaceutical Analysis |
| title | Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411) |
| title_full | Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411) |
| title_fullStr | Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411) |
| title_full_unstemmed | Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411) |
| title_short | Assay method for quality control and stability studies of a new antimalarial agent (CDRI 99/411) |
| title_sort | assay method for quality control and stability studies of a new antimalarial agent cdri 99 411 |
| url | http://www.sciencedirect.com/science/article/pii/S2095177913000397 |
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