The main objective of the study aimed at developing and validating the advanced effective Liquid-Liquid Extraction method for evaluating Sulfamethoxazole in Human plasma, by following the FDA guidelines using UPLC-MS/MS and Sulfamethoxazole D4 as Internal Standard. The analyte was eluted using Acetonitrile: 10mM Ammonium Formate pH 4.5 (60:40 v/v) flows through the column and flow-rate of 0.400mL/min. The injected volume set was 5µl. Chromatogram obtained with isocratic elution with efficient separation. Spiking concentrations were fixed for the Calibration Curve and Quality Control samples that produced the linearity over the range of 320.635ng/ml to 22009.900ng/ml for the standard curve. The slope 0.0000535324 and corresponding intercept was plotted using the developed method. The method has been validated according to all established parameters of inter and intra precision and accuracy and showing recovery of 71.39% and 71.14% for SM and SMD4 respectively. Reinjection and Reproducibility and Auto Sampler Carry Over Test were met with the specifications. The validated method drew accuracy and meets specifications for the Big Batch, Hemolyzed and Dilution Integrity samples. This assay method was developed that proves all the stability parameters for the matrices as well as solutions used for the study and suitable for the bioequivalence study. The proposed method may also be applicable for the study of combined formulations.
For perseverance of a simple, fast and selective procedure were developed in drug substance and its pharmaceutical preparations. the proposed project, a successful attempt has been made to develop a simple, accurate, economic and rapid method for the estimation and to validate the method. As a result, a simple, economical, precise and accurate method was developed and validated by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). The main objective for that is to improve the conditions and parameters, which should be followed in the development and validation. developed Reverse phase HPLC technique was done utilizing filtered and degassed pH-6.0 Acetate buffer as a Mobile phase-A and pH-6.0 Acetate buffer and organic mixture in the ratio of 30:70 as a Mobile phase-B. By using waters X-Bridge C18 (150*4.6mm), 3.5µm column separation was achieved. The flow rate and run time was 0.8mL/min and 45minutes. The detection wavelength was 265nm.The average percentage recovery for related compound-C was found to be 94.3%, 95.9%, 96.0% represents the accuracy of the method and for related compound-D was found to be 95.8, 95.4 and 96.4. The %RSD for related compound-C was found to be 5.576 and for related compound-D was found to be 1.588 represents the precision of the method. The correlation coefficient square for , related compound-C and related compound-D was found to be 0.999999, 0.9992 and 0.9991 respectively. Respective parameters met the acceptance criteria, from the results concluded that the developed method was precise and accurate.
The purpose or intent of this current study was to establish a fast and sensitive HPLC technique for the perseverance of Fludrocortisone acetate and utilizing best frequently used HPLC technique. This method had been validated as per the ICH requirements to assure that the method consistently meets the predetermined specifications and quality attributes.Utilizing filtered and degassed pH 3.0 Phosphate buffer and Acetonitrile in the ratio 90:10 as a Mobile phase-A and pH 3.0 Phosphate buffer and Acetonitrile in the ratio 65:35 as a Mobile phase-B the established RP-HPLC technique was done. The separation was achieved by using Waters, X-Bridge Shield RP18, (150 X 4.6-mm), 3.5-µm column. Run time and Flow rate was set 45minutes and 1.2mL/min. Injection volume 100µL and wavelength was set 240nm.The correlation coefficient square for fludrocortisones acetate and Fludrocortisone Impurity was found to be 0.9991 and 0.99997. The SD and %RSD for Fludrocortisone Impurity was found to be 0.02 and 1.48 represents method precision. Following validated parameters lies within the limit. Hence, the developed method was precise, simple, fast and accurate.
Objective: The main aim of this study is to compare the effectiveness of treatment of osteoarthritis (OA) with hydroxychloroquine against diclofenac and to compare the safety of the treatment of OA with hydroxychloroquine against diclofenac. The secondary objectives are the comparison of onset and duration of action of both the treatments.Methods: A prospective interventional study has been done in a tertiary care teaching hospital for 1 year from January 2016 to December 2016. The interventional model included an active control (diclofenac - nonsteroidal anti-inflammatory drugs). The control group received diclofenac 75 mg for 12 weeks, whereas the test group received hydroxychloroquine 200 mg for 3 months.Results: Pain control is significantly rapid in diclofenac group, whereas the duration of action is significantly increased in hydroxychloroquine. It can be clearly seen that the hydroxychloroquine group significantly increases the quality of life when compared to diclofenac group. It is clearly seen that the incidence of gastric ulcers is more common in diclofenac group when compared to hydroxychloroquine group.Conclusion: Hydroxychloroquine offers a newer spectrum in the management of OA. Although it is slow acting, it has significantly increased the quality of patient as it can have a prolonged action. Hence, hydroxychloroquine can be used as a newer entity in the management of OA.
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