DEVELOPMENT OF SPECTROPHOTOMETRIC AND FLUOROMETRIC METHODS FOR ESTIMATION OF DARUNAVIR USING QBD APPROACH

Objective: The main objective of the present study is to develop newer simple, precise spectrophotometric and fluorometric methods of estimation for Darunavir using coupling agent O-pthaladehyde.Methods: The experimental work was designed for both spectroscopic and fluorometric method development and validation. The method is based on formation complex of Darunavir with O-pthaladehyde. QbD approach was applied by varying different parameters. These parameters were designed into Ishikawa diagram.Results: The complex Darunavir-Phthalaldehyde in methanol with 0.1 N HCl showed linearity for both spectrophotometric and fluorometric methods. The calibration curve by spectrophotometry is linear in concentration range of 2-22 µg/ml with regression coefficient (R2) = 0.998 at 355 nm and for fluorometry it is linear in concentration range of 0.5-5.0 ng/ml with regression coefficient (R2) = 0.999. This method was found to be rugged and robust in different testing criteria with % RSD less than 2. The limit of detection and limit of quantification was found to be 0.2 μg/ml and 0.8 μg/ml for a spectrophotometric method and 0.12 μg/ml and 0.43 μg/ml for fluorometric method respectively.Conclusion: Both methods were found to be precise with % RSD of less than 2. The % recovery of the spectrophotometric and fluorometric methods was found to be 101.04 %, 98.15 % respectively. In this way, the results of all validation parameter were within the limits as per International Conference on Harmonization guideline.Â

Quality-of-life among elderly with untreated fracture of neck of femur: A community based study from southern India

Background and Objectives: Owing to the high prevalence of osteoporosis and falls, elderly people are at risk of developing hip fractures. The objective of the current study is to assess the quality-of-life (QOL) of elderly (>60 years) with untreated hip fractures in a rural developmental block in Southern India. Methodology: Twenty-one elderly with an untreated fracture neck of femur were identified with the help of community level health workers. EuroQol (EQ-5D) was administered to assess the QOL before and after the event. QOL was also assessed among a comparison group, matched for age and sex among neighborhood people. Wilcoxon signed rank test and Mann-Whitney U test were used to compare EQ-5D mean scores with before the event scores and the comparison group scores respectively. Results: Of people with hip fracture, 57.1% (12/21), 76.2% (16/21), 81% (17/21), 52.6% (11/21) and 85.7% (18/21) reported severe problems with mobility, pain, usual activity, self-care and anxiety respectively. The EQ-5D mean score among the elderly with fracture neck of the femur was 0.08 (SD 0.27). It was low when compared with the same subjects before the occurrence of the event (Z –4.05, P < 0.001) and as compared with the comparison group (Z –5.77 P < 0.001). Conclusion: The QOL scores assessed using EQ-5D index scores was poor among people with untreated fracture neck of the femur as compared with the comparison group and also as compared to their status before the occurrence of the event. A vast majority of study participants reported severe problems with mobility, pain, usual activity and self-care and anxiety domains of EQ-5D questionnaire