• Mekala Mounika
• M. Tandrima
• M.VENKATESH
• Dr.A.Yasodha

In the present work simple and precise Reversed Phase - High Performance Liquid Chromatography method have been developed for the estimation of Mirtazapine in bulk form and Marketed Pharmaceutical dosage form.The method developed for the determination of Mirtazapine in Mirtazapine in bulk form and Marketed Pharmaceutical dosage form involved using RP-HPLC which incorporated a Phenomenex Luna C18 (4.6×150mm, 5µm), in isocratic mode, with mobile phase comprising of Water: Methanol in the ratio of 55:45 (v/v). The flow rate was 0.9 mL/min and the detection was monitored at 225 nm. The total run time was 6.0 min and the column was maintained at 40ºC temperature.Mirtazapine was eluted in the given mobile phase with a retention time (tr) of 2.958 min. The linearity for the quantification of Mirtazapine was 5.0 – 25.0 µg/mL (R2 =0.9773, Y= 237972x + 521600) with coefficients of variation (based on mean peak area for six replicate injections) in the range 7.5 to 22.5. The limits of detection and of quantification were 1.4 and 4.3 µg/mL, respectively. Recovery of the method was found to be 99.8 % whiles the relative standard deviation (RSD) of intra-day and inter-day precision was 0.616 and 0.847, respectively. Method precision was found to be 0.194%, respectively. The proposed RP-HPLC method is simple, sensitive, rapid, cost-effective and accurate for the determination of Mirtazapine in both bulk materials and marketed pharmaceutical dosage forms.

Mirtazapine, RP-HPLC, Accuracy, Precision, Linearity, ICH Guidelines.

"METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF MIRTAZAPINE IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 9, page no.d82-d91, September-2023, Available :http://www.jetir.org/papers/JETIR2309310.pdf

"METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF MIRTAZAPINE IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 9, page no. ppd82-d91, September-2023, Available at : http://www.jetir.org/papers/JETIR2309310.pdf