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Development and Validation of RP-HPLC Method for Determination of Amlodipine Besylate, Telmisartan and Rosuvastatin Calcium from Synthetic Mixture
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| Author:
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BINNY MEHTA, HIRAK JOSHI, UJASH SHAH, PINAK PATEL
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| Abstract:
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The key planned feature of the current work is to establish and validate a swift, efficient selective, and accurate
RP-HPLC system for the simultaneous determination of Amlodipine Besylate, Telmisartan, and Rosuvastatin
Calcium in a synthetic mixture. The isolation of these two drugs was accomplished by the Hiber ODS C18
column (150 x 4.6 mm) by a mixture of Acetonitrile: 0.05M Phosphate buffer: Methyl alcohol (40:30:30v/v)
with 1ml Triethylamine having pH 3.0 as eluent at a flow rate of 1ml/min and elute was monitored for
quantification at 254nm. Eluted components were observed to be at 1.639, 3.064, and 4.213 minutes
respectively for Amlodipine, Telmisartan, and Rosuvastatin. The linearity was done in the range of 2-10 µg/ml
(r2=0.999), 16-80 µg/ml (r2=0.9972), and 4-20 µg/ml (r2=0.9976) for Amlodipine Besylate, Telmisartan, and
Rosuvastatin Calcium respectively. Accuracy (recovery) was between 98.6 and 99.84%. The system was
statistically tested for linear regression, retrieval, identification threshold, quantification limit, accuracy, and
precision as per ICHQ2R1 guidelines and was successfully applied for quantitative analysis of a synthetic
mixture of Amlodipine Besylate, Telmisartan, and Rosuvastatin Calcium.
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| Keyword:
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RP-HPLC, Amlodipine Besylate, Telmisartan, Rosuvastatin Calcium, Validation
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.704
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| Download:
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Request For Article
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