ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Two validated stability-indicating chromatographic methods for the separation of two anti-hypertensive combinations in the presence of their degradation products or impurities

Noha Samy Mostafa, Ghada AbdElHamid, Hala Elsayed Zaazaa, and Sawsan Mohamed Amer

Cairo University, Cairo, Egypt

E-mail: noha.ayesh@pharma.cu.edu.eg

Abstract: Two RP-HPLC methods were developed, optimized, and validated for the determination of two different anti-hypertensive combinations in the presence of their degradation products or impurities and in their pharmaceutical formulations. The first mixture is Ramipril (RAM) in combination with Amlodipine besylate (AML) [mixture I], while the second one is a combination of Ramipril (RAM), Atorvastatin (ATV), and Aspirin (ASP) [mixture II].The proposed combinations were successfully separated on X-bridge C₁₈column (250 × 4.6 mm i.d, 5 µm p.s.), using a mobile phase of 0.05 M phosphate buffer-acetonitrile-THF (60:40:0.1% by volume) pH 2.5 and an isocratic mobile phase formed of acetonitrile-0.05 M phosphate buffer-THF (60:40:0.1% by volume) pH 2.5 for mixture (I) and (II) at a flow rate of 1 mL/min and 1.2 mL/min, respectively. The compromising components of the mixtures were detected at 218 nm. For the best separation of the mentioned components different parameters were examined and optimized. The two suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the quantification of the cited components in presence of their obtained degradation products as well as in their commercial pharmaceutical formulations. For both methods the obtained results were statistically analyzed and compared to those of the official and reported methods; using Student’s t test and F test showing no significant difference with high accuracy and good precision.

Keywords: Anti-hypertensive combination ; Stability-indicating ; Liquid chromatography 

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-019-00792-z

Chemical Papers 73 (10) 2427–2439 (2019)