Posted by admin on Jul 31, 2025 in |
The detection and quantification of nitrosamine impurities in pharmaceutical products are critical due to their potential carcinogenicity. This study presents the development of a sensitive Gas Chromatography-Mass Spectrometry (GC-MS) method for the analysis of nitrosamine impurities in Apixaban drug substance. The method demonstrates high specificity, sensitivity, and compliance with regulatory guidelines, ensuring the safety and quality of Apixaban for therapeutic use. The method, designed to detect harmful contaminants in apixaban, performs effectively and meets all essential standards. The Mass spectrometry technique accurately confirmed the presence of NDMA, NDEA, and NEIPA at specified retention times. In accordance with established guidelines, the method underwent multiple parameters during development & validation ensuring its accuracy, sensitivity, and reliability, confirming the ability to detect these pollutants even at trace levels. The system operates continuously without interference from other pharmaceuticals, making it particularly suited for targeting these specific impurities. The method demonstrates the ability to detect minute quantities of nitroso-contaminants, utilizing well-established limits of detection and quantification. Recovery rates ranged from 96% to 103%, indicating...
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Posted by admin on Jul 31, 2025 in |
Introduction: IECs seek a duly filled application form to provide the overview of the study as per ICMR guidelines in the process of review and to maintain study related records. Aim and Objectives: To evaluate the errors and completeness of research application forms submitted to IEC. Materials and Methods: The present study was undertaken after obtaining approval from IEC, GMC, Kathua. Application forms from January 2023 to December 2024 were analysed regarding: Type of studies, study duration and design, title, detail and signature of investigators, informed consent process, involvement of the vulnerable population, declaration of conflict of interest. Results: Total43 application forms were analysed in which details of principal & co-investigators were incomplete in 19 (44.18%), duration of study was not mentioned in 18 (41.18%), consent forms were missing in 17 (39.5%) forms. The signatures of the head of department and investigators were missing in 14 (32.5%) and 11 (25.58%) forms respectively. All forms mentioned complete title, aims & objectives, background and specified about DCGI permission. Conclusion: Current study...
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Posted by admin on Jul 31, 2025 in |
An efficient and high yield synthesis of Siamenoside I (1), from Mogroside V (2) is reported. Siamenoside I (1) was obtained by enzymatic hydrolysis of Mogroside V (2). Bioconversion process involved enzymatic modification followed by separation and purification processes, including reversed-phase chromatography. The final product, a dried white powder, undergoes several stages of concentration, reaction, filtration, and freeze-drying. Siamenoside I (1) was isolated and characterized with NMR (1H, 13C, 1H-1H COSY, 1H-13C HSQC-DEPT, 1H-13C HMBC, 1H-13C HSQC-TOCSY, 1H-1H ROESY and 1D-TOCSY) and mass spectral data. This Siamenoside I (1) possess a 1->2 beta sugar linkage between sugar II and sugar I, making it’s structural properties unique. The sensory and spectral properties of Siamenoside I (1) synthesized from mogroside V (2) or isolated from fruit have the same characteristics. Additionally, we emphasize the importance of 1D and 2D NMR techniques when identifying complex...
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Posted by admin on Jul 31, 2025 in |
The aim of this study is to assess the antibacterial efficacy of the Datura stramonium seeds and leaves extracts against Mycobacterium kansasii. The antimicrobial experiments were performed using five doses (0.25µg/ml, 0.50µg/ml, 1µg/ml, 2µg/ml, 4µg/ml) of seeds and leaves extracts. The results showed notable inhibitory effects on Mycobacterium kansasii. The results indicated that the extract of D. stramonium exhibited action against all the tested bacterial isolates, with the level of activity varying depending upon the concentration. The hexane extract of seeds DSS-1H exhibited antibacterial activity, with mean zones of inhibition measuring 98.94±50.25.%, 120.98±56.92%, 120.499±69.60%, 125.752±133.18% and 89.494±180.63%, at the doses of 0.25, 0.50, 1, 2, and 4 µg/ml and while treating with DSS-2A the percent cell viability of the microbial cell was found to be 128.02±25.64%, 86.79±14.95%, 34.61±16.33%, 26.29±29.76% and 32.56±19.48% at the doses of 0.25, 0.50, 1, 2 and 4µg/ml, respectively, with incubation period of 48 hours. Similarly, the microbial cells were treated (0.25, 0.50,1,2,4 µg/ml) with DSS-3ET with incubation period of 48 hours, indicating a more substantial...
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Posted by admin on Jul 31, 2025 in |
A sensitive, specific and precise HPTLC method for simultaneous estimation of Fenofibrate and Rosuvastatin has been developed and validated. The method employed aluminium plates pre-coated with silica gel 60 F254 as the stationary phase. The solvent system consisted of n-Hexane: Acetone: Ethyl acetate: Glacial acetic acid (4: 5: 0.9: 0.1, v/v/v/v) which was found to give compact and dense spots for Fenofibrate and Rosuvastatin (RF value 0.83 ± 0.05 and 0.35 ± 0.05 respectively). Densitometric analysis of both drugs was carried out at 300 nm. Linear relationship was found with calibration curve for linearity in concentration range of 25-75 mg/spot and 167-501 mg/spot for Rosuvastatin and Fenofibrate with Correlation coefficient value 0.992 and 0.991 respectively. This method was found to be good percentage recovery for Rosuvastatin and Fenofibrate in between 98% to 102%. All parameters of validation of the formulations were found within the limit as per ICH...
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