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Authors : *R. Vani, B. Vijaya Kumar, Anas Rasheed
Abstract : The present study is carried out for the analytical development and formulation of ramipril and hydrochlorothiazide in combination with selective excipients. The objective of drug and excipient compatibility considerations and practical studies is to delineate, as quickly as possible, real and possible interactions between potential formulation excipients and the Active Pharmaceutical Ingredient (API). This is an important risk reduction excercise early in formulation of drugs. A specific and accurate reverse phase ultra-performance liquid chromatographic method was developed for the excipient compatibility studies of selective excipients in bulk drugs (Ramipril and Hydrochlorothiazide). The developed method consists of mobile phase, is a mixture of two solutions mobile phase A and mobile phase B in the ratio of 30:70. Mobile Phase A(Buffer and methanol in the ratio of 93:7, the buffer used is Sodium phosphate). Mobile Phase B (100 % Acetonite ) with gradient programming, Hypersil BDS C18, The size of the column is 100 mm x 2.1 mm, 1.7 μm column as stationary phase with a flow rate of 0.1 mL/min and the PDA detector is employed. With the proposed method the compatibility of the excipients with bulk drugs was found to be acceptable under the guidelines of ICH-Q8 (R2) and the excipients with bulk drugs are then subjected forauthenticated formulations and are assayed for purity of formulated tablets with marketed product for comparable studies. The in vitro dissolution studies were also carried out. The drug content obtained from the prepared formulations is also within the limits and comparable with the marketed product, Cardace. The formulated tablets have shown promising results in the invitro dissolution studies.

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