Design And Validation Of A Combination Of Iso-Sorbide Dinitrate And Hydralazine Hydrochloride As An Rp-Hplc Stability Indicator Method

Abstract

This study established and validated an RP-HPLC technique for the simultaneous detection of Hydralazine Hydrochloride and Iso-sorbide dinitrate in combination tablet dosage forms. Reliability, accuracy, and precision characterise the method. To achieve chromatographic separation, a 55:45 v/v mixture of acetonitrile and 0.02 M phosphate buffer was used, along with a C18 column (250 mm × 4.6 mm, 5 μm particle size) that had its pH adjusted to 3.0 using orthophosphoric acid. With a constant flow rate of 1.0 mL/min, the UV detection was performed at 230 nm. Under these conditions, the peaks presented by iso-sorbide dinitrate (3.74 minutes) and hydralazine hydrochloride (5.58 minutes) were clearly visible. Complete method validation was carried out in line with ICH Q2(R1) guidelines. Linearity, accuracy, precision, specificity, robustness, limit of detection (LOD), limit of quantification (LOQ), and system adaptability were significant criteria in the validation process. Studies of accuracy and precision confirmed the method's reliability, while studies of forced degradation confirmed its specificity and stability-indicating capability by successfully separating the APIs from their degradation products under a range of stress conditions, including acidic, basic, oxidative, thermal, and photolytic pressures. This approved RP-HPLC method is a dependable tool for quality control laboratories. It may be used for routine pharmaceutical analysis and stability testing, ensuring that high-quality, safe, and effective combined formulations of Iso-sorbide dinitrate and Hydralazine Hydrochloride are produced