HPTLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND CELECOXIB IN PURE AND COMBINED DOSAGE FORM

HPTLC is simple, reliable, precise and accurate for separation and identification of drug in a combined dosage form which gives satisfactory accuracy in results when applied on amlodipine besylate (Amlo) and celecoxib (Celo). Toluene, ethyl acetate, methanol and conc. ammonia (6:5:1.5:0.3 v/v/v/v) was required as a mobile phase for separation and identification of drugs. These drugs were scanned by densitometry at 310 nm. The developed method was validated for linearity, precision, accuracy, LOD, and LOQ. The linearity range and correlation coefficient for Amlo and Celo were obtained to be 100 to 600 ng/ml and 2 to 12 μg/ml, 0.9971, and 0.9989, respectively. The results of the recovery study for Amlo and Celo have obtained the range of 99.52% to 99.83% and 99.83% to 99.98%, respectively. The method precision was established by repeatability study. LOD and LOQ are 17.88µg/ml and 54.20 µg/ml for Amlo and 0.39µg/ml and 1.20µg/ml for Celo, respectively. The statistical parameters and recovery data indicated that the method may be engaged for efficient, rapid drug analysis from tablet formulation. The percentage label claim present in tablet formulation was obtained to be 100.25% and 99.93% for Amlo and Celo, respectively. The outcomes of analysis clearly specified that with no interference from excipients in the formulation.