UV-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF LORNOXICAM IN MICROSPONGES

Objective: To develop and validate a novel, specific, precise and simple UV-spectrophotometric method for the estimation of lornoxicam present in microsponges.Methods: UV-spectrophotometric determination was performed with Thermo Scientific Evolution 201 UV-Vis spectrophotometer using methanol as a medium. The spectrum of the standard solution was run from 200-400 nm range for the determination of absorption maximum (λ max). λ max of lornoxicam was found at 353 nm. The absorbance of standard solutions of 3, 6, 9, 12 and 15, µg/ml of drug solution was measured at an absorption maximum at 353 nm against the blank. Then a graph was plotted by taking concentration on X-axis and absorbance on Y-axis which gave a straight line. Validation parameters such as linearity and range, selectivity and specificity, LOD and LOQ, accuracy, precision and robustness were evaluated as per ICH guidelines.Results: Linearity for the UV-spectrophotometric method was noted over a concentration range of 3.0-15.0 µg/ml with a correlation coefficient of 0.9995. The limit of detection (LOD) and limit of quantification (LOQ) for lornoxicam was found at 1.26 μg/ml and 3.82 μg/ml respectively. Accuracy was in between 99.21 and 99.60%. % RSD for repeatability, intraday precision and interday precision were found to be 0.473, in between 0.478 and 0.619 and in between 0.855 and 1.818 respectively. The proposed UV method is found to be robust.Conclusion: The proposed UV-Visible spectrophotometric method was validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed method is sensitive, precise, reliable and simple for the estimation of lornoxicam present in microsponges

DEVELOPMENT AND VALIDATION OF A SIMPLE UV-SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF CIPROFLOXACIN HCL PRESENT IN TASTE MASKED DRUG RESIN COMPLEX

Objective: The objective of this study was to develop and validate a novel, specific, precise and simple UV-spectrophotometric method for the estimation of ciprofloxacin HCl present in taste-masked drug-resin complex.Methods: UV-spectrophotometric determination was performed with ELICO SL 1500 UV-Vis spectrophotometer using 0.1 N HCl as a medium. The spectrum of the standard solution was run from 200-400 nm range for the determination of absorption maximum (λ max). λ max of ciprofloxacin HCl was found at 276 nm. The absorbance of standard solutions of 1, 2, 3, 4, 5 and 6 µg/ml of drug solution was measured at an absorption maximum at 276 nm against the blank. Then a graph was plotted by taking concentration on X-axis and absorbance on Y-axis which gave a straight line. Validation parameters such as linearity and range, selectivity and specificity, limit of detection (LOD), limit of quantification (LOQ), accuracy, precision and robustness were evaluated as per ICH guidelines.Results: Linearity for the UV-spectrophotometric method was noted over a concentration range of 1-6 µg/ml with a correlation coefficient of 0.9995. The limit of detection (LOD) and limit of quantification (LOQ) for ciprofloxacin HCl was found at 0.46 μg/ml and 1.38 μg/ml respectively. Accuracy was in between 98.89 and 99.27%. % RSD for repeatability, intraday precision and interday precision were found to be 1.271, in between 0.351 and 0.659 and in between 1.067 and 1.769 respectively. The proposed UV spectrophotometric method is found to be robust.Conclusion: The proposed UV-spectrophotometric method was validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed method is sensitive, precise, reliable and simple for the estimation of ciprofloxacin HCl present in taste-masked drug-resin complex

FORMULATION AND EVALUATION OF LORNOXICAM MICROSPONGES USING EUDRAGIT RS 100 AND EUDRAGIT RSPO

Objective: The objective of the present study was preparation and evaluation of lornoxicam microsponges to prolong their drug release up to 12 h for effective osteoarthritis, rheumatoid arthritis, and acute lumbar-sciatica therapy.Methods: Lornoxicam microsponges were prepared by the quasi-emulsion solvent diffusion technique using different concentrations of polymers such as Eudragit RS 100 and Eudragit RSPO in ethanol and dichloromethane organic solvent mixture. Microsponges were evaluated for their particle size, percentage yield, entrapment efficiency, scanning electron microscopy (SEM), and in vitro drug release studies.Results: The percentage yield, entrapment efficiency, average particle size, and in vitro drug release for optimized formulation F12 were found to be 70.23% w/w, 81.34% w/w, 172.72 μm, and 96.64% up to 8 h, respectively. From SEM, it was observed that microsponges were found to be spherical in shape with rough surface texture. The formulation F12 shows zero-order release kinetics with an r2 value of 0.961 and the value of Korsmeyer–Peppas model was found to be 0.792; it follows super case II non-Fickian diffusion. The in vitro drug release studies showed that formulations comprised varying concentrations of Eudragit RSPO in higher proportion exhibited much-retarded drug release as compared to formulations comprised a higher proportion of varying concentrations of Eudragit RS 100.Conclusion: Among all the formulations F12 shows better results, which are released more than 80% of the drug release within 8 h; hence, it is optimized. These developed microsponges are releasing the drug for a longer period, which will be effective for osteoarthritis, rheumatoid arthritis, and acute lumbar sciatica therapy

ULTRAVIOLET-SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF NORFLOXACIN PRESENT IN TASTE MASKED DRUG RESIN COMPLEX

 Objective: The objective of this study was developed and validated a novel, specific, precise, and simple ultraviolet (UV)-spectrophotometric method for the estimation of norfloxacin present in taste masked drug-resin complex.Methods: UV-spectrophotometric determination was performed with ELICO SL 1500 UV-visible spectrophotometer using 0.1 N HCl as a medium. The spectrum of the standard solution was run from 200 to 400 nm range for the determination of absorption maximum (λ max). λ max of norfloxacin was found at 278 nm. The absorbance of standard solutions of 1, 2, 3, 4, and 5 μg/ml of drug solution was measured at an absorption maximum at 278 nm against the blank. Then, a graph was plotted by taking concentration on X-axis and absorbance on Y-axis which gave a straight line. Validation parameters such as linearity and range, selectivity and specificity, limit of detection (LOD) and limit of quantification (LOQ), accuracy, precision, and robustness were evaluated as per the International Conference on Harmonization (ICH) guidelines.Results: Linearity for the UV-spectrophotometric method was noted over a concentration range of 1–5 μg/ml with a correlation coefficient of 0.9995. The LOD and LOQ for norfloxacin were found at 0.39 μg/ml and 1.19 μg/ml, respectively. Accuracy was in between 99.00% and 99.17%. % relative standard deviation for repeatability, intraday precision, and interday precision was found to be 0.600, in between 0.291 and 0.410, and in between 0.682 and 1.439, respectively. The proposed UV spectrophotometric method is found to be robust.Conclusion: The proposed UV-spectrophotometric method was validated according to the ICH guidelines, and results and statistical parameters demonstrated that the developed method is sensitive, precise, reliable, and simple for the estimation of norfloxacin present in taste masked drug-resin complex