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Vol. 8, Issue 8 (2019)

RP-HPLC method development and validation for the simultaneous estimation of hydrochlorothiazide and amlodipine in tablet dosage form

Author(s):
J Naga Mohan Reddy, R Sai Bharath, G Chinnareddaiah and K Vinod Kumar
Abstract:
A simple, selective, rapid, precise and economical reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed for simultaneous estimation of Hydrochlorothiazide (Hctz) and Amlodipine (Amlo) in tablet dosage forms. The method is carried out on C18 (25 cm x 4.6 mm i.d., 5μm) column with a mobile phase consisting of methanol (MeOH): Phosphate buffer 50 mmol (KH2PO4, 0.05M) (pH adjusted to 5.5 using o-phosphoric acid) in the ratio of 75:25 (v/v). The retention time of Hctz and Amlo is 3.2 and 5.1 min, respectively, with the flow rate of 1 mL/min with diode array detection at 236 nm. The linear regression analysis data from the linearity plot showed good linear relationship with a correlation coefficient (R2) value for Hctz and Amlo of 0.9969 and 0.9958 in the concentration range for Hctz is 10-35μg ml-1 and Amlo is 4-14 μg ml-1, the assay report of Hctz and Amlo is 98.4 and 99.6%. The relative standard deviation for intraday precision has been found to be <2.0%. The method is validated according to the ICH guidelines. The developed method is validated in terms limit of detection, limit of quantitation, robustness and solution stability. The proposed method can be used for simultaneous estimation of these drugs in marketed dosage forms.
Pages: 276-280  |  627 Views  91 Downloads


The Pharma Innovation Journal
How to cite this article:
J Naga Mohan Reddy, R Sai Bharath, G Chinnareddaiah, K Vinod Kumar. RP-HPLC method development and validation for the simultaneous estimation of hydrochlorothiazide and amlodipine in tablet dosage form. Pharma Innovation 2019;8(8):276-280.

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