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- Title
FORCED DEGRADATION STUDY OF DEVELOPED AND VALIDATED RP-HPLC METHOD FOR DETERMINATION OF ONDANSETRON AND RANITIDINE IN BULK AND FORMULATION.
- Authors
Shaikh, T. J.; Khan, Majid; Deore, Hemant; Badgujar, V. L.; Sehjad, Surti; Azeem, Syed Abdul; Juned, Pinjari; Roshan, Shaikh; Lovhare, Rahul; Aatif, Shaikh; Mugni Danish, Mohammad Abdul; Yaheeya, Mohammad
- Abstract
During study of Ondansetron and Ranitidine in bulk and dosage form, a forced degradation study has been carried out with development and validation of RP-HPLC method. At a flow rate of 1 ml/min, the chromatographic conditions were optimized using a mobile phase of Acetonitrile: Water (0.1% OPA) (25:75). The detection was carried out at 314 nm. Particle size capacity of column was 5 μm and Column (C18) of 4.6 × 250 mm dimension was used as a stationary phase. Forced degradation or stability studies was carried out by exposing a drug solution into four different stress conditions like Hydrolytic, Acidic, Alkaline, and oxidative. The method was validated according to ICH guidelines for linearity, Accuracy, precision (Interday), LOD and LOQ. The response was found to be linear in concentration range of 50-300 mmg/ml of Ranitidine and 4-20 mgm/ml of Ondansetron. During Interday Precision of Ranitidine and Ondansetron, %RSD found were less than 2%. LOD of Ranitidine & Ondansetron was found to be 2.1518 and 0.1158, respectively. LOQ of Ranitidine and Ondansetron was found to be 6.5207 and 0.3509, respectively. The method was linear, simple, precise and accurate and therefore suitable for routine analysis of drugs in formulation.
- Subjects
ONDANSETRON; RANITIDINE; HIGH performance liquid chromatography; HYDROCHLOROTHIAZIDE; DRUG analysis
- Publication
Biochemical & Cellular Archives, 2024, Vol 24, Issue 1, p347
- ISSN
0972-5075
- Publication type
Article
- DOI
10.51470/bca.2024.24.1.347