DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD OF BISOPROLOL AND AMLODIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sufiyan Ahmad; Md. Rageeb Md. Usman; Mohammed Imran; Vinod A. Bairagi; Rohit S. Patil

Volume : X, Issue : V, May - 2020

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD OF BISOPROLOL AND AMLODIPINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Sufiyan Ahmad, Md. Rageeb Md. Usman, Mohammed Imran, Vinod A. Bairagi, Rohit S. Patil

Abstract :

The objective of the recent study was to develop a simple, accurate and precise RP–HPLC method with subsequently validate as per ICH guidelines for the determination of Amlodipine (AMLO) and Bisoprolol Fumarate (BISO) using mobile phase (mixture of a Methanol: Water (0.1%OPA) 65:35 v/v) as the solvent. The proposed method involves the measurement of Retention time at analytical wavelength 230 nm was selected. The Retention time of Amlodipine and Bisoprolol Fumarate was found to be 3.49 and 6.52 min respectively. The linearity of the proposed method was investigated in the range of 5–25 µg/ml for both the drugs Amlodipine and Bisoprolol Fumarate. The method was validated for its linearity, accuracy and precision. Both inter–day and intra–day variation was found to be showing less 2 % RSD