Abstract
:This paper presents the development and validation of a method for the simultaneous analysis of Cetirizine hydrochloride (CTZ) and Phenylephrine hydrochloride (PHE) using high performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel G 60F254 plates. The mobile phase is comprised of Toluene: Ethyl acetate: Methanol: Ammonia (5:2:3:0.4 v/v/v/v). Detection wavelength was 254 nm. The Rf values were 0.31 30 ± 0.05 and 0.49 ± 0.05 for PHE and CTZ, respectively. The linear regression analysis data for the calibration plots showed a good linear relationship with r2 ≥0.999 in the concentration range of 2–12 μg for both drugs. The method was validated for accuracy, precision, robustness, and specificity, limit of detection and limit of quantitation. Statistical analysis proves that the method is repeatable and selective for estimation of both the drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.
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