Revista estadounidense de administración avanzada de fármacos Acceso abierto

Abstracto

New Antihypertensive Tablets Formulation and HPLC Analyses Using New Generation Core Shell Column

Kamlesh K. Dutta, Zeid A. Al-Othman, Govinda Manda and Imran Ali

Objectives: Formulation of triplet combined solid dosage film coated tablet containing amlodipine besylate (equivalent to 5 mg amlodipine), hydrochlorothiazide (12.5 mg) and losartan potassium (50 mg) for the treatment of severe hypertension. Development and validated of a simple, fast, precise, selective and accurate HPLC method for the simultaneous determination of amlodipine besylate, hydrochlorothiazide and losartan potassium in the tablets. Methods: The formulation of the tablets was carried out as per standard protocols. The various steps involve in formulation were dispensing of raw materials, sieving, preparation of granulating solvent, mixing, granulation, drying (In FBD), lubrication, compression and coating. The separation of these three drugs was achieved on a Sun Shell C8 column (150 mm x 4.6 mm, 2.6 μm) with phosphate buffer-acetonitrile (70:30% v/v) as mobile phase at 1.0 mL/min flow rate and 230 nm detection. Results and Conclusion: The physical parameters of tablets were satisfactory with average weight deviation from 3.23 to 3.29%, friability 0.04%, disintegration time 8.3 minutes, average hardness 85.43N and thickness from 3.92 to 4.01 mm. The assay was found to be 99.89%, 99.99% and 99.97% of amlodipine, hydrochlorothiazide and losartan potassium, respectively. The dissolution was found to be 98.8 to 99.70%, 97.85 to 98.95% and 97.98 to 99.99% of amlodipine, hydrochlorothiazide and losartan potassium, respectively. The uniformity of content was 99.85 to 99.99% and 99.60 to 99.99% of amlodipine and hydrochlorothiazide, respectively. The retention times observed were to be 7.338, 2.097 and 10.675 minutes for amlodipine besylate, hydrochlorothiazide and losartan potassium, respectively. The method was statistically validated for linearity, recovery, limit of detection, limit of quantification, accuracy,precision, robustness, stability of drugs in pure form and in presence of matrices and forced degradation study. The method was successfully applied for analysis of combined dose tablet.