Abstract
A sim ple, specific , accurate , rapid , inexpensive isocratic Reversed Phase - High Performance Liquid Chromatography (RP - HPLC) method was developed and validated f or the quantitative determin ation of Amlodipine besylate and Hydrochlorothiazide in pharmaceutical tablet dosage forms and HPLC method was used for an in vitro dissolution study of tablets containing the above drugs. RP - HPLC method was developed by using W elchrom C 18 Column (4.6 X 250 mm, 5 µm), Shimadzu LC - 20AT Prominence Liquid C hromatograph. The mobile phase composed of 10 mM P hosphate buffer (pH - 3.0, adjusted with triethylamine) : acetonitrile ( 50 : 50 v/v ) . The flow rate was set to 1.0 mL . min - 1 with the responses measured at 2 30 nm using Shimadzu SPD 20A Prominence UV - V is detector. The dissolution test was performed using 900 mL of distilled water as the dissolution media at 50 rpm using an USP Apparatus II at 37°C. The retention time s of Hydrochlorothiaz ide and Amlodipine besylate were found to be 3.373 min utes and 3.753 min utes respectively . Linearity was established for Amlodipine besylate in the range of 1 - 5 µg / mL with correlation coefficient 0.999 5 and Hydrochlorothiazide in the range of 3 - 15 µg / m l with correlation coefficient 0.9996 . The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quanti t ation. The developed method can be used for routine quality contr ol analysis of Amlodipine besylate and Hydrochlorothiazide in pharmaceutical tablet dosage form.
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