Method development and validation for the estimation of mirtazapine by using UV spectrophotometer with different order of derivatives
1 Department of Quality Assurance SGMSPM’s Sharadchandra Pawar College of Pharmacy, Otur, Pune 412409, Maharashtra, India.
2 Department of Pharmaceutics SGMSPM’s Sharadchandra Pawar College of Pharmacy, Otur, Pune 412409, Maharashtra, India.
Research Article
GSC Biological and Pharmaceutical Sciences, 2022, 19(02), 196–204.
Article DOI: 10.30574/gscbps.2022.19.2.0191
Publication history:
Received on 13 April 2022; revised on 16 May 2022; accepted on 19 May 2022
Abstract:
A precise, accurate, effortless, and inexpensive UV spectrophotometric was developed and authenticated for the appropriate estimation of Mirtazapine in bulk and marketed formulation. The solution consisting of Mirtazapine was being scanned over by UV- visible rays, ranging from its maximum wavelength absorbance. The numerous calibrations of standard Mirtazapine were formulated, and the absorbance for each was documented in response to the maximum wavelength. A graph was then plotted with the documented values of Concentration with that of the absorbance. Owing to this graph, the range and linearity were calculated. The varied analytical frameworks namely, accuracy, precision, LOD, and the LOQ were being enumerated, by the means of QC control. The derivative spectrophotometric method was established, which also authenticates all the parameters in consideration. The First to the Fourth Order Derivative of spectrophotometric was being computed, in the specified ranges of 200 nm to 400 nm. At around 222 nm, a sharp peak was observed. The Calibration Curve was plotted against concentration vs. absorbance. The selected maximum wavelength was considered 222 nm. A separate study was being conducted to test the accuracy and precision of the method, and the results generated were quite satisfactory. The drug consisting of 50 %, 75%, and 100% of – had appreciable recoveries within the range of 98 to 100%. These results claim that the method is safe and accurate. The Limit of Detection (LOD) and the Limit of Quantitation (LOQ) were also computed for the method. This method is also certified by the International Conference of Harmonization (ICH). All the validation parameters were within acceptable ranges. Thus, this method was determined and was used for successful application in the estimation of the amount of Mirtazapine present in pharmaceutical formulations.
Keywords:
UV Spectroscopy; Analysis; Linearity; %Recovery; Derivative; Precision; Mirtazapine
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