ABSTRACT
Objective: The current research work focus to simple and rugged bioanalytical method development and validation of brivudine in human plasma using high-performance liquid chromatography. Methods: The analyte (Brivudine) and internal standard (Sofosbuvir) were extracted using the Solid Phase Extraction (SPE) technique. The chromatographic separation was accomplished by using Zorbax eclipse XDB-C18 Column (150×4.6 mm, 5 μm) with a mobile phase consisted of Methanol: 0.5% Ortho-phosphoric acid (65:35%, v/v) respectively, at a flow rate of 0.7 mL/min. The developed method was validated by performing system suitability, carryover effect, linearity, selectivity, sensitivity, precision, accuracy, recovery, ruggedness, and stability studies. The method was validated as per USFDA guidelines. Results: The selected chromatographic condition was found to efficiently separated brivudine (RT-3.55 min) and ISTD (RT-7.87 min). The assay demonstrated a linear dynamic range of 85.205 to 4500.246 ng/ml for brivudine in human plasma with r2>0.99. Demonstrated the lowest limit of detection at 85.205 ng/ml. This method established an intra-run and inter-run precision within the range of 2.99-6.31%CV and 3.67-5.80%CV, respectively. Additional intra-run and inter-run accuracy were within the range of 97.55-105.37% and 99.27-102.15%, respectively. The mean percentage recovery of brivudine and ISTD studies proved good extraction efficiency and the robustness was also evaluated. Conclusion: A simple, accurate, precise, linear and rugged RP-HPLC method was developed and validated for the estimation of brivudine in human plasma with K2EDTA anticoagulant and suitable for conducting BA/BE and TDM.
ABSTRACT
Background: Pain is one of the most common and uncomfortable consequences of surgery, feared by all. Effective and rapid relief from pain is always a challenge but is necessary for alleviating nocioception – induced responses like endocrine-metabolic responses to surgery, autonomic reflexes with adverse effects on organ function, reflexes leading to muscle spasm, and other undesirable results. Aim of the study: This study was done to compare the efficacy of intrathecal fentanyl with bupivacaine and buprenorphine with bupivacaine for all lower abdominal and lower limb surgeries. Materials and methods: Totally 60 ASA I and II patients of both sexes for different lower abdominal and lower limb surgeries were chosen for the study and the patients were divided into two groups of 30 patients in each group. Group F received 3 ml of 0.5% hyperbaric bupivacaine with 25 mcg fentanyl and group B received 3 ml of 0.5% hyperbaric bupivacaine with 75 mcg of buprenorphine. In our study, the time taken to achieve T10 level of the sensory blockade was considered as the time of V. Muruganantham, Nalini, Naheed Azar. A comparative study between the efficacy of fentanyl with bupivacaine 0.5% and buprenorphine with bupivacaine 0.5% for lower abdominal and lower limb surgeries in a Government Tertiary Care Teaching Hospital. IAIM, 2019; 6(5): 80-86. Page 81 onset of sensory block tested with pinprick method, motor block assessed by the onset of Bromage scale 3 and it was found that onset of the sensory block with bupivacaine + Fentanyl was earlier than compared with bupivacaine + Buprenorphine. Results: In the postoperative period VAS scores were significantly low for the buprenorphine group (Group B) when compared with fentanyl group (Group F). Conclusion: To summarize buprenorphine has higher efficacy with intrathecal bupivacaine, prolonged duration of postoperative analgesia and also analgesic-sparing effect in the post-operative period when compared to fentanyl.