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Simultaneous Estimation of Amlodipine Besylate and Candesartan Cilexitil by HPTLC Method in their Combined Dosage Form
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| Author:
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MADHURI A.HINGE, DIPTI PATEL
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| Abstract:
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A simple, precise, accurate high-performance thin-layer chromatographic technique was developed and
validated as per ICH guidelines for simultaneous estimation of Amlodipine Besylate and Candesartan Cilexetil
in the tablet dosage form. TLC plates 60 F-254 pre-coated with silica gel and Toluene: Ethyl acetate: Methanol:
Diethylamine (5:3:2:0.5, v/v/v/v) was used as mobile phase for the development of the method. Densitometric
scanning of the developed plates in the UV region by taking 275 nm as wavelength in Camag scanner. Rf value
for Amlodipine Besylate and Candesartan Cilexetil was found to be 0.45 and 0.65 respectively. The method
was validated in accordance to the ICH guidelines, for linearity, precision (intra- and inter-day), limit of
quantitation and limit of detection, robustness, and accuracy. Linearity range for Amlodipine Besylate and
Candesartan Cilexetil was found to be 300-1500 ng/spot and 480-2400 ng/spot and regression coefficient was
found to be 0.9993 and 0.9990 respectively. Limit of detection for Amlodipine Besylate and Candesartan
Cilexetil was found to be 14.13 and 11.06 ng/spot and limit of quantitation were found to be 42.84 and 33.54
ng/spot for Amlodipine Besylate and Candesartan Cilexetil, respectively. The method is applicable for the
determination of Amlodipine Besylate and Candesartan Cilexetil simultaneously in the formulation. The
developed HPTLC method is precise, repeatable, accurate, and suitable for the analysis of Amlodipine Besylate
and Candesartan Cilexetil in a formulation.
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| Keyword:
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Amlodipine Besylate, Candesartan Cilexetil, HPTLC
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.106
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| Download:
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