RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AZELNIDIPINE AND TELMISARTAN IN PHARMACEUTICAL DOSAGE FORM BY QBD APPROACH
Abstract“Quality by Design” (QbD) serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based holistic and proactive approach for development of pharmaceutical products. So, the present work describes the development of RP-HPLC method for simultaneous estimation of azelnidipine and telmisartan in pharmaceutical dosage form by QbD approach. The Box-Behnken design was used for screening where the effect of flow rate, % organic phase and temperature on retention time, resolution, number of theoretical plates (NTP) and symmetry factor (critical quality attributes) was evaluated. Chromatogram was run through Discovery C18 250 x 4.6 mm, 5m. Mobile phase containing 0.01N Ortho Phosphoric Acid: Acetonitrile taken in the ratio of 53.8:46.2V/V was pumped through column at a flow rate of 0.9 ml/min. The developed method was validated according to guidelines of the International Conference on Harmonization (ICH). Hence, the developed method using QbD approach was better understood that, reduces the time and cost of the analysis.
Article Information
23
5760-5770
1188 KB
472
English
IJPSR
R. S. Sakhare *, M. D. Padole, S. S. Tondare, A. H. Gaherwar, M. H. Muratkar and N. P. Savant
Department of Pharmaceutical Quality Assurance, Channabasweshwar Pharmacy College (Degree), Kava Road, Basweshwar Chowk, Latur, Maharashtra, India.
ramsakhare85@gmail.com
18 April 2023
04 July 2023
28 July 2023
10.13040/IJPSR.0975-8232.14(12).5760-70
01 December 2023
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