Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF RAMIPRIL AND METOLAZONE IN COMBINED TABLET DOSAGE FORM.

Manzoor Ahmed*, Manohara Y.N, Rachana R. Yeligar

ABSTRACT

The objective of the current study was to develop a simple, accurate, precise and rapid RP-HPLC method with subsequently validate as per ICH guidelines for the determination of Ramipril (RAM) and Metolazone (MET) using mobile phase [mixture of water and acetonitrile in the ratio of 70:30 and potassium dihydrogen ortho phosphate buffer of pH-3 (using OPA)] as the solvent. The proposed method involves the measurement of Retention time at selected analytical wavelength. 220.0 nm was selected as the analytical wavelength. The retention time of MET and RAM was found to be 4.245 and 6.567 respectively. The linearity of the proposed method was investigated in the range of 10-50 μg/ml (r = 0.9999) for MET and 20-100 μg/ml (r = 0.9998) for RAM respectively. The method was statistically validated for its linearity, accuracy and precision. Both inter-day and intra-day variation was found to be showing less % RSD (Relative Standard Deviation) value indicating high grade of precision of the method.

Keywords: RP-HPLC method, Metolazone, Ramipril, Validation.