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Development and validation of RP-HPLC method for the estimation of pidotimod in tablet dosage form
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| Author:
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GAYATRI GAGE, MITHUN RUDRAPAL, ANIL G. JADHAV, ATUL R. BENDALE, LAXMIKANT B. BORSE
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| Abstract:
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A simple, accurate and precise RP-HPLC method was developed and validated for the determination of pidotimod in the marketed tablet dosage form. The chromatographic analysis was carried out on a cosmosil C18 column (250 mm × 4.6 i.d., particle size: 5 µm) using the mixture of methanol and water (60:40 % v/v) as a mobile phase at a flow rate of 0.8 ml/min with UV detection at 203 nm. The method was validated as per the requirements of ICH guidelines in terms of various validation parameters such as linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD), limit of quantitation (LOQ) and system suitability. From validation studies, it is evident that the developed analytical method is practically valid and useful. In all validation experiments, the % RSD (relative standard deviation) values are less than 2% indicating high validity as well as reliability of the developed method. The amount of pidotimod estimated in the tablet formulation was found to be 100.37%. On the basis of our present findings, it is concluded that the developed method can be used for the route analysis of pidotimod in bulk drug as well as in the tablet dosage form.
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| Keyword:
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Pidotimod, RP-HPLC, Analytical validation, ICH, Reproducibility, RSD
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.04.010
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| Download:
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