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VALIDATED STABILITY INDICATING HPLC-DAD METHOD FOR THE SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND OLMESARTANMEDOXOMIL IN MIXTURE

Abstract

Objective: The development of a simple and reliable HPLC-DAD procedure was described for the assay of the drug combination containing Amlodipine Besylate (AMB) and OlmesartanMedoxomil (OLM).Such mixture in tablet form is used for the treatment of hypertension. Methods: Effective chromatographic separation was achieved on licosphere 100 RP-C8 (250 x 4.6, 5µm) in a relatively short time (3 & 7.6 min for OLM and AMB respectively). The mobile phase was adjusted to be acetonitrile : 0.2MM KH2PO4 of pH 6 : triethanolamine ratio (53:42:5).The reliability and performance of the proposed procedure was statistically validated with respect to linearity, ranges, precision, accuracy, selectivity, detection and quantification limit (LOD&LOQ). Results: Calibration curves were linear in the range of 1-25 and 5-60 µg.mL-1 for AMB and OLMrespectively with correlation coefficient (r) ˃ 0.9993. The calculated % relative error (Er%) and % relative standard deviation (%RSD) were less than 2% for both drugs indicating good accuracy and precision. Conclusion: The validated HPLC-DAD method was successfully applied for the analysis of AMB & OLM in laboratory made tablets with high accuracy exhibiting no interfering peaks from the auxiliary tablet ingredients.The proposed method made use of HPLC –DAD as tool for quality control in compounding AMB and OLM in combination. Keywords: OLM; AMB; HPLC-DAD;combined dosage forms.

Author(s)

Marwa K. El Jamal

Coauthor(s)

M. Abdelhady El Sayed, Ekram M. Hassan

Journal/Conference Information

International Journal of Pharmacy and Pharmaceutical Sciences ,Vol 6, Issue 4, 2014