Validated HPTLC method for simultaneous quantitation of Olmesartan medoximal and Amlodipine besylate in bulk drug and formulation
By Dhanshri J. Desai, Archana S. More, Aniruddha R. Chabukswar, Bhanudas S. Kuchekar, Swati C. Jagdale and Pradeep D. Lokhande
A new, simple, precise, and accurate HPTLC method for simultaneous quantitation of olmesartan medoxomil (OLME) and amlodipine besylate (AMLO) as the bulk drug and in tablet dosage forms have been developed. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of Chloroform: Methanol: Toluene: Acetic acid (8:1:1:0.1 v/v/v/v). Densitometric evaluation of the separated zones was performed at 254 nm. The two drugs were satisfactorily resolved with RF values of 0.45 ± 0.02 and 0.15 ± 0.02 for OLME and AMLO, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (800-5600ng spot-1 for OLME and 200-1400ng spot-1 for AMLO), precision (intra-day RSD 0.65–1.33% and inter-day RSD 0.97–1.45% for OLME, and intra-day RSD0.83–1.35% and inter-day RSD1.42–1.68% for AMLO), accuracy for OLME and AMLO afford 98-102%, and specificity, in accordance with ICH guidelines.
Key words: Olmesartan medoxomil, Amlodipine besylate, densitometry, validation, quantification.