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...
moreObjectives: 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.