DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF GEMCITABINE HYDROCHLORIDE IN BULK AND POLYMERIC NANOPARTICLES

Objective: The objective of the present work was to develop and validate a novel, specific, precise and reliable method for estimation of gemcitabine hydrochloride in bulk and polymeric nanoparticles using UV-visible spectroscopy method.Methods: The UV-Visible spectrophotometric determination was performed with double beam Systronics UV-visible spectrophotometer; model UV-2201 (India). The proposed methods were validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, and formulation analysis as per international conference on harmonization (ICH) guidelines.Results: The method was based on measurement of absorbance at wavelength maxima i.e. 267.2 nm, λmax of the drug in distilled water, phosphate buffer pH 6.8 and 7.4. The method obeyed Beer Lambert's law in the concentration range of 5-30 µg/ml andR2-value was found to be 0.999. Moreover, the % drug recovered from polymeric nanoparticles was found to be 97.97%.Conclusion: According to results, the currently developed method shows compliance with acceptance criteria with Q2 (R1) and international conference on harmonization (2005) guidelines, because the % RSD was found to be less than 2%. The developed method was simple, accurate and précised

Preserved quality of life in octogenarians at early, mid, and late follow-up intervals irrespective of cardiac procedure.

Cardiac surgery has become established in octogenarians over the past decade. This study assessed the quality of life (QOL) and survival in patients undergoing various cardiac procedures at various time intervals postoperative. Patients older than 80 years at the time of their cardiac procedure were initially included (n = 427). Patients were grouped according to the time interval from their operations namely as within 3 years postoperative (Group A), 3-5 years postoperative (Group B), and older than 5 years postoperative (Group C). Patients who were at least 2 years postoperative and who were still alive were sent the Medical Outcomes Study Short Form 12 Health Survey version 2 QOL questionnaire (n = 308). In results, there were no significant differences in the preoperative characteristics among the groups including type of surgery and logistic Euroscore. There were also no significant differences in the immediate postoperative phase in the complication rates except for renal replacement therapy (P < 0.01). At follow-up, a further 20 patients had died, and for those still alive 87% (61 of 70), 86% (86 of 100), and 74% (87 of 118) of patients returned questionnaire for each group, respectively. There were no significant differences in mental scores (P = 0.3) and physical scores (P = 0.07) among the groups at the various time intervals. This was irrespective of the type of surgery performed on multivariate analysis. Moreover, most octogenarians who underwent cardiac surgery had equivalent or better QOL than expected when compared with the general population of the same age and sex. In conclusion, the QOL in octogenarians undergoing cardiac surgery is preserved, irrespective of the interval from and the type of procedure. Octogenarians enjoy a good QOL, both physical and mental performance, irrespective of the time interval after surgery and the type of cardiac surgery that they have undergone. Based on these data, any type of cardiac surgery should still be an option in this age group including complex cardiac procedures