Objective: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial quality by design approach was established and validated for Ambroxol (AMB) by reversed-phase high-performance liquid chromatography (RP-HPLC). Methods: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), limit of quantitation (LOQ), accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, ultraviolet (UV) diode-array detection and Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6 mm × 100 mm; 2.5 μm), a 20 μl injection loop and UV730D Absorbance detector at 244 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% orthophosphoric acid) Water (75:25) of pH 3 as mobile phase setting flow rate 0.7 ml/min at ambient temperature the retention time of AMB were found to be 4.85 min. The industrialized method was found linear over the concentration range of 10–50 μg/ml for AMB while the LOD and LOQ of AMB was found to be 0.5174–0.2739 μg/ml, analytical method that concluded. Conclusion: There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate, and stability indicating method was developed with high degree of practical utility.
Objective: A simple rapid, accurate, precise, and reproducible validated reversed-phase high performance liquid chromatography method was developed for the determination of emtricitabine (EMB) and tenofovir (TEN) in bulk and tablet dosage forms. Methods:The quantification was carried out using symmetry Premsil C 18 (250 mm×4.6 mm, 5 µm) Younglin (S.K.) gradient way using mobile phase comprising of methanol:water (70:30 v/v) pH 3 and a detection wavelength of 273 nm, and injection volume of 20 µL, with a flow rate of 1 ml/minutes. Results:In the developed method, the retention time of EMB and TEN were found to be 3.1667 minutes and 7.5000 minutes. The developed method was validated according to the International Conference on Harmonization (ICH) guidelines. Conclusion:The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible. Hence, it is worthwhile that the proposed methods can be successfully utilized for the routine quality control analysis EMB and TEN in bulk drug as well as in formulations.
Background and Objectives: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial QbD approach was established and validated for Naproxen (NPX) and Pantoprazole (PPR) by RP-HPLC. Method: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, LOD, LOQ, accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, UV (DAD) & Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6mm x 100mm; 2.5µm), a 20µl injection loop and UV730D Absorbance detector at 239 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% OPA) Water (75:25) of pH 3 as mobile phase setting flow rate 0.7 ml/min at ambient temperature. The developed method was found linear over the concentration range of 10-50 μg/ml for NPX and 4-20 μg/ml for PPR while detection and quantitation limit were found to be 0.2375 (ug/mL) and 0.7199 (ug/mL) for NPX and 0.1028 (ug/mL) and 0.3059 (ug/mL) PPR. Conclusion: There are no interfering peaks underperformed degradation conditions.
In December 2019, several patients from Wuhan, China were admitted with symptoms of pneumonia. As the number of patients presenting with similar symptoms started to rise, the causative agent was eventually isolated from samples. It was initially called the 2019 novel coronavirus (2019-nCoV) and has been recently relabelled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); the disease it causes has been named coronavirus disease 2019 (COVID-19). Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness. The best way to prevent and slow down transmission is be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol based rub frequently and not touching your face. The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it's important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow). At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments. WHO will continue to provide updated information as soon as clinical findings become available. Since the virus is spreading worldwide, on March 31, 2020, the WHO officially described the COVID-19 outbreak as a pandemic.
Objective: A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Meloxicam drug (MLX) in pharmaceutical mixture. Methods: Effective chromatographic separation achieved using a phenomenex luna C 18 (4.6 mm, 250 mm, 5 μm) column with isocratic elution by the mobile phase composed of 0.02 M Potassium dihydrogen orthophosphate, pH adjusted to 4 with orthophosphoric acid (filtered): acetonitrile (50:50) respectively. The flow rate is 1.0 ml/min on detecting wavelength 220 nm. Results: The proposed HPLC method was statistically validated with respect to linearity, ranges, precision, accuracy, selectivity, LOD, LOQ and robustness. The retention time (RT) of Meloxicam was found to be 6.0 min. respectively. All parameters were found to be within the acceptance limit. The calibration curve was linear in ranges of 3-6, 6-9, and 15-18 mg/ ml for Meloxicam. The R 2 of Meloxicam was found to be 0.996 respectively. Conclusion: A novel simple, simple, sensitive, precise, rapid, accurate and economical and reliable RP-HPLC method was developed and validated for the Meloxicam suppository.
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