DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD OF PALIPERIDONE PALMITATE IN BULK AND ITS APPLICATION FOR DRUG LOADING AND ENTRAPMENT EFFICIENCY ANALYSIS OF LONG ACTING INJECTABLE MICROSPHERES
Objective: The objective of current study was to develop simple, precise and cost effective ultra violet (UV) spectroscopic method for estimation of paliperidone palmitate (PP) as bulk and in polymeric depot dosage form.
Methods: UV spectrophotometer with quartz samples cells and spectral manager software was used for analysis samples. 20 % Methanol in Mili-Q-Water was used as solvent for sample and standard preparations. Method validation was carried out as per ICH Q2 (R1) guidelines. Stress degradation studies were carried out to check stability indicating performance of developed method. The validated method was applied for estimation of PP content of long acting injectable microspheres of PP.
Results: The wavelength of maximum absorption was found to be 283 nm. The proposed method was validated in the range of 5-30 µg/ml of PP. Mean recovery for 80%, 100% and 120% standard solution was found to be 99.03%, 99.21% and 99.35% respectively with less than 2% relative standard deviation (RSD). Intra-day and inter-day method precision ranged from 0.54 to 1.62% and 0.67 and 1.24% respectively. Limit of detection (LOD) and limit of quantitation (LOQ) were estimated to be 0.03 and 0.10 µg/mL respectively. The developed method was found to be robust and rugged. Stress degradation studies carried out under acidic, alkaline, hydrolytic, and oxidative and photo stress. The proposed method was capable to detect changes in assay due to stress conditions.
Conclusion: The developed method was successfully employed for routine analysis of drug loading in long acting injectable microspheres of PP.
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