Aim: The proposed study aimed to develop a novel ultra-performance liquid chromatography (UPLC) method for the estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet dosage form and validate the method in accordance with the International Conference on Harmonization guidelines. Methods: The optimized conditions for the developed UPLC method are Acquity UPLC HIBRA C18 (100mm × 2.1mm, 1.8µ) column maintained at 30°C with a mobile phase consisting of Buffer (0.01N sodium hydrogen phosphate) pH adjusted to 4.0 with dil. orthophosphoric acid: Acetonitrile in the ratio of 60:40%v/v on isocratic mode at a flow rate of 0.3mL/min. Results and conclusion: The sample was detected at 220nm. The retention time for Ertugliflozin and Sitagliptin was deemed at 1.873min and 1.260min. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness, and solution stability. The method obeyed Beer’s law in the concentration range of 3.75µg/mL to 22.5µg/mL for Ertugliflozin and 25µg/mL to 150µg/mL for Sitagliptin with a correlation coefficient of 0.999 for Ertugliflozin and Sitagliptin respectively. Forced degradation studies were conducted by exposing the drug solution to numerous stress conditions such as acidic, basic, peroxide, neutral, photolytic, and thermal conditions. The net degradation was considered within the limits, indicating that the drug is stable in stressed conditions. The developed method for the estimation of Ertugliflozin and Sitagliptin can be utilized for the routine analysis of Pharmaceutical dosage form.
A reverse phase HPLC method is described for the determination of famciclovir in bulk and tablets. Chromatography was carried on a C 18 column using a mixture of acetonitrile, and glacial acetic acid (70:30 v/v) as the mobile phase at a flow rate of 1 ml min-1 with detection at 310 nm. The retention time of the drug was 3.56 min. The detector response was linear in the concentration of 1-40 μg/ml. The limit of detection and limit of quantification was 0.335 and 1.014 μg ml-1 respectively. The method was validated by determining its sensitivity, linearity, accuracy and precision. The proposed method is simple, economical, fast, accurate and precise and hence can be applied for routine quality control of famciclovir in bulk and tablets.
Objective: The present study was aimed to develop a novel, simple, rapid accurate and precise, stability-indicating reversed-phase high-performance liquid chromatography method for the simultaneous estimation of sofosbuvir, velpatasvir, and voxilaprevir in bulk and tablet dosage forms. Methods: The chromatographic elution was achieved in isocratic mode using the combination of sofosbuvir, velpatasvir, and voxilaprevir in the ratio of acetonitrile and water (65:35%v/v) using a Phenomenex C18 column which has specification (150 × 4.6 mm, 5 μ particle size) and the flow rate of 1.0 ml/min and wavelength (ultraviolet) detection at 220 nm. Results: The retention time obtained for sofosbuvir, velpatasvir, and voxilaprevir was 2.213 min, 2.568 min, and 2.917 min, respectively. Sofosbuvir, velpatasvir, and voxilaprevir and their combination drug product were exposed to acidic, alkali, thermal, photolytic, and oxidative stress conditions. The current method was validated according to the ICH guidelines for accuracy, precision, linearity, specificity, and sensitivity. Conclusion: The method developed is more sensitive, accurate, precise, and robust then the methods reported earlier. Retention time and run time were decreased; hence, the method is economical simple and precise. Forced degradation studies indicated for the suitability of the method for stability studies of sofosbuvir, velpatasvir, and voxilaprevir. The proposed method can be used for routine quality control analysis test in pharmaceutical industries.
Objective: The present study aimed to develop a stability-indicating reverse-phase high performance-liquid chromatography (RP-HPLC) method for the estimation of Sofosbuvir, Velpatasvir, and Voxilaprevir in tablet dosage form and validated in accordance with ICH guidelines. Methods: The optimized conditions for the developed RP-HPLC method are Agilent C18 (250 mm×4.6mm, 5μ) column maintained at 30ºC with a mobile phase consisting of Buffer(0.1%OPA) and Acetonitrile taken in the ratio 55:45%v/v on isocratic mode at flow rate 1.0ml/min. The sample was detected at 220 nm. Results: The retention time of Sofosbuvir, Velpatasvir, and Voxilaprevir was found to be 2.17, 2.731 and 3.55 min respectively. The developed method was validated for accuracy, precision, specificity, ruggedness, robustness and solution stability.
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