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Article Detail
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HPLC Method Development, Validation and Stability Study of Metformin, Voglibose and Teneligliptin in Bulk and Combined Dosage Form
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| Author:
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ASMITA SAKORE, MAHAVEER SINGH, SAGAR WANKHEDE, BIRENDRA SHRIVASTAVA
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| Abstract:
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The main aim of the research is to establish a simple, economical, responsive HPLC system in which teneligliptin, metformin and voglibose can be combined simultaneously. Analysis was conducted using the Methanol: water (65:35v/v) mobile stage at pH 3 with a cosmosil C18 column (250mm x 4.6Id, particle size: 5µ). The detection took place at the flow rate of 232nm, 0.8ml/min. Metformin, Voglibose and Teneligliptin were respectively 4.4min, 5.8min, 6.9min. Linearity levels for MET, VOG were found to be between 250-1250 µg/ml and TEN were 0,1-0,5 µg/ml. It was identified that the percentages for MET, VOG & TEN were 99.84%, 100.24%, 99.94%. Detection limits have been found for MET, VOG & TEN, 0.99ug/ml, 0.001ug/ml, 0.10ug/ml respectively for MET, VOG and TEN. The quantitation limits for MET, VOG, and TEN respectively were 2.87 ug/ml, 0.0042 U/ml, 0.332 ug/ml. In acidic, alkaline, oxidative, photolytic and thermal conditions, the strength-degradation analysis was conducted according to ICH guidelines. The approach has been successfully tested and found to be within the limit for all parameters. The method developed has been tested for linearity, precision, accuracy, device suitability and can be used effectively for quality control analysis according to ICH guidelines.
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| Keyword:
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Metformin, Tenelegliptine, Voglibose, Rp-HPLC, validation, stability study.
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.265
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| Download:
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