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VOL. 11, ISSUE 2 (2026)
A Novel RP-HPLC method development and validation for quantitative determination of Ramipril and Hydrochlorothiazide in bulk and marketed solid dosage form
Authors
N A Porwar, K A Patil, K K Khadke, K G Suryawanshi, Y R Patil, Dr. K R Patil, S N Patil, Dr. S D Barhate
Abstract
A simple, rapid, and reliable reverse-phase
high-performance liquid chromatography (RP-HPLC) method was developed and
validated for the simultaneous determination of ramipril (RMP) and
hydrochlorothiazide (HCT) in bulk and tablet dosage forms. Chromatographic
separation was achieved using an Eclipse Plus C18 column (250 mm × 4.6 mm, 5 µm
particle size) with a mobile phase consisting of acetonitrile and phosphate
buffer (40:60 v/v, pH 3.0) at a flow rate of 1.0 mL/min. Detection was carried
out at 210 nm. The retention times for RMP and HCT were found to be
approximately 3.31 min and 6.64 min, respectively, with a total analysis time
of less than 10 minutes.The method exhibited good linearity over the
concentration range of 2–12 µg/mL for RMP and 4–24 µg/mL for HCT, with
correlation coefficients (r²) of 0.999 for both drugs. The method was validated
according to ICH guidelines and showed satisfactory accuracy, precision,
robustness, and specificity. Recovery studies demonstrated accuracy within
99–100%, and %RSD values were less than 2 %, indicating high precision. The
limits of detection (LOD) and quantification (LOQ) confirmed the sensitivity of
the method. The validated method was successfully applied for the analysis of
commercial tablet formulations, showing no interference from excipients. The
results indicate that the proposed RP-HPLC method is suitable for routine
quality control analysis of ramipril and hydrochlorothiazide in pharmaceutical
formulations.
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Pages:39-44
How to cite this article:
N A Porwar, K A Patil, K K Khadke, K G Suryawanshi, Y R Patil, Dr. K R Patil, S N Patil, Dr. S D Barhate "A Novel RP-HPLC method development and validation for quantitative determination of Ramipril and Hydrochlorothiazide in bulk and marketed solid dosage form". International Journal of Research in Pharmacy and
Pharmaceutical Sciences, Vol 11, Issue 2, 2026, Pages 39-44
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