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HPTLC method development and validation for simultaneous estimation of Olmesartan medoximil, Amlodipine besylate and Hydrochlorothiazide in bulk drug and formulation

J.Saminathan, T.Vetrichelvan

In this study a new simple, precise and accurate HPTLC method has been developed for simultaneous estimation ofOlmesartanmedoxomil,Amlodipine besylate and Hydrochlorothiazide in pharmaceutical dosage forms. Chromatographic separation of the drugs was performed on precoated silica gel 60 F254 plates usingChloroform:Methanol: Formic acid (8.5:1.5:0.25, v/v/ v). A TLC scanner set at 254 nm was used for the direct evaluation of the chromatogramin reflectance-absorbancemode. The drugswere satisfactorily resolvedwithRf values of0.57 ± 0.02, 0.36 ± 0.04 and 0.21 ± 0.02 for Olmesartan medoxomil, Amlodipine besylate and Hydrochlorothiazide. The accuracy and reliability of the method was assessed by evaluation of linearity (200- 2000 ng/spot for OLME, 50-500 ng/spot forAMLO and 125-1250 ng/spot forHCTZ), precision (intra-dayRSD0.4510%, inter-dayRSD, 0.2773%and analyst to analyst RSD0.1959 forOLME, intra-dayRSD1.0216%, inter-day RSD0.3137%, analyst to analystRSD0.8557%forAMLO) (intra-dayRSD 0.4117%, inter-dayRSD 0.2974%and analyst to analyst RSD0.2038%for HCTZ, accuracy forOLME,AMLOandHCTZafford 98-102%and specificity in accordance with ICH guidelines. This HPTLCMethod had the potential to determine these drugs simultaneously from dosage forms without any interference.