Uv-Spectrophotometric Method Development and Validation for the Determination of Lornoxicam in Microsponges

Abstract

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 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 were evaluated as per ICH guidelines.99.21 and 99.60%. 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.% 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. INTRODUCTIONLornoxicam is a new NSAID belonging to the oxicam class. It is a strong analgesic and anti-inflammatory NSAID as compared to other NSAIDs. Chemically its 6-chloro-4-hydroxy-2-methyl-N-2-pyridyl-2H-thieno-[2, 3-e]-1,2-Thiazine-3-carboxamide-1,1-dioxide. Like all NSAIDs, it is also having anti-inflammatory and antipyretic (fever reducing) properties [1]. It is available in oral and parenteral formulations. Lornoxicam is a yellow or slightly yellow powder [2]. It is slightly soluble in water, soluble in methanol, ethanol and isopropyl alcohol [3].In the treatment of osteoarthritis and rheumatoid arthritis, lornoxicam is given by mouth in a daily dose of 12 mg in two or three divided doses. Lornoxicam is given in doses of 8-16 mg daily by mouth for the treatment of pain. Similar doses may be given by intravenous or intramuscular injection, although in rare cases the maximum initial daily dose may be increased to 24 mg; treatment by injection should be limited to two days [4].Lornoxicam is a non-selective inhibitor of the enzyme cyclooxygenase, inhibiting both the cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) isoenzymes. Cyclooxygenase catalyzes the formation of prostaglandins and thromboxane from arachidonic acid. Prostaglandins act as messenger molecules in the process of inflammation [5,6]. Fig. 1:The l...

DEVELOPMENT OF UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BENIDIPINE HYDROCHLORIDE BY USING QUALITY BY DESIGN (QbD) APPROACH

“…Results are reported in table 6. These results indicated the high sensitivity of the proposed UV method [26].…”

Method Validation of Simvastatin in PCL-Peg-PCL Triblock Copolymer Micelles Using Uv-Vis Spectrophotometric for Solubility Enhancement Assay

“…Accuracy indicates the closeness of the measurement results to the actual value which is expressed as % recovery, while precision indicates the degree of suitability of the test results as measured by the distribution of the results from the average when repeated measurements are made which will produce an average value that is very close to the true value. The measuring parameter to determine precision is the percent relative standard deviation (% RSD) [16,17,28]. The precision test results are shown in table 5 and 6 show that the % RSD of the average SIM absorbance obtained was 1.371, 0.418, and 0.786 for the intra-day measurement, while 0.418 for the first day and 0.525 for the second day on the inter-day measurement with a concentration of 10 g/ml.…”

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

“…The proposed UV method for the estimation of paliperidone palmitate was validated in terms of parameters like linearity, range, precision, robustness, ruggedness, accuracy and sensitivity. The method was validated as per the guidelines of the International Conference on Harmonization (ICH) [19][20][21].…”

“…The sensitivity of measurements of PP by the use of the proposed method was estimated in terms of the limit of detection (LOD) and limit of quantitation (LOQ) [20,21]. The sensitivity data of the study were shown in table 7.…”