A simple, precise and reproducible RP-HPLC method was developed for the estimation of related substances in tilorone dihydrochloride. Quantification was performed using a Zorbax SB-phenyl column (150 × 4.6mm, 5µ) with mobile phase A: 20mM potassium dihydro phosphate + 2ml of triethylamine, pH 2.30 and mobile phase B: acetonitrile, methanol and water 60: 20: 20% v/v. A gradient program was followed with a run time of 55 minutes at a flow rate of 1.0 ml/min. The column temperature was maintained at 40°C, the injection volume was 10 µl and the detection was performed at 269nm using a PDA detector. The retention time of Tilorone dihydrochloride was found to be 10.36 minutes. The proposed method has been validated according to the ICH guidelines for Linearity, Precision, Accuracy, LOD, and LOQ. The method was linear from 0.157 - 3.934μg/ml for standard, 0.153-3.820μg/ml and 0.166 - 4.140μg/ml for impurities, TLHC01 and TLHC02 respectively. The impurities TLHC01 and TLHC02 have been mapped in all stress conditions. The LOD and LOQ of TLHC01 were found at 1.757μg/ml and 5.857μg/ml and 1.919μg/ml and 6.396μg/ml respectively for TLHC02 respectively. Statistical analysis showed that the method was precision, reproducible, selective, specific and accurate for the analysis of Tilorone dihydrochloride and its impurities. The wide range of linearity, sensitivity, precision, short retention times and simple mobile phase have shown that the method is suitable for the routine quantification of mass impurities of tilorone hydrochloride and its dosage pharmaceutical forms with high precision and accuracy.
A simple and reproducible method of isocratic reverse phase liquid chromatography (RP-LC) was developed for the quantitative determination of oseltamivir phosphate in bulk drug and capsules, used to treat antiviral (influenza). The proposed RP-HPLC method uses X terra C18, 4.6 mm, 150 mm 4.6 mm i.d. column (at room temperature), using 0.1% octa-sulfonic acid: acetonitrile 30: 70 v / v, effluent flow rate (1.0 ml / min) and UV detection at 237 nm for oseltamivir analysis. The method was validated according to the ICH guidelines in terms of specificity, linearity, precision and accuracy. The retention time for oseltamivir was 2.31 min. The recovery determinations allowed the calculation of a confidence interval from 99.79 to 101.30% with a relative standard deviation value of 0.5%. LOD and LOQ were estimated at 2.98 and 9.98 µg/mL respectively. The validated method was successfully applied to the determination of oseltamivir in dosage form in capsules (Tamiflu 75 mg, Roche). Oseltamivir was exposed to conditions of acid, basic, oxidative and thermal stress and the stressed samples were analyzed with the proposed method. The chromatographic peak purity results indicated the absence of elution peaks with the main oseltamivir peak, which demonstrated the specificity of the test method for estimating oseltamivir in the presence of degradation products. This method has advantages that include a short execution time, a simple and rapid sample preparation which makes this method used for routine oseltamivir analysis in quality control laboratories.
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