High performance liquid chromatographic assay of amlodipine, valsartan and hydrochlorothiazide simultaneously and its application to pharmaceuticals, urine and plasma analysis

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2020-10, Vol.1155, p.122295-122295, Article 122295
• Main Authors: Shaikh, Javed Shaikh Afzal, Raut, Santosh, Abdul, Ahad, Pathan, Mohd Arif Ali Khan
• Format: Article
• Language: English
• Subjects: Amlodipine; Amlodipine - analysis; Assay; Chromatography, High Pressure Liquid - methods; Force degradation; High performance liquid chromatographic; Hydrochlorothiazide - analysis; Internal standard; Limit of Detection; Linear Models; Reproducibility of Results; Tablets; Valsartan; Valsartan - analysis
• ISSN: 1570-0232; 1873-376X
• DOI: 10.1016/j.jchromb.2020.122295

•Method developed for simultaneous assay of Amlodipine, Valsartan and Hydrochlorothiazide.•Pioglitazone used as internal standard.•Method is stability indicating as recommended by ICH.•It is validated for different validation parameters.•The present analytical method has a widespread linear concentration range augmenting.•The method has applicability to different strength of A.V.H. tablet formulations.•The method may also be applied for simultaneous assay of analytes in plasma and urine. A Simple, Specific, Precise, Accurate, Linear, Rugged, Robust High Performance Liquid Chromatographic method of analysis for simultaneous determination of assay of Amlodipine, Valsartan and Hydrochlorothiazide drugs in the pharmaceuticals tablet formulations using Pioglitazone as a common internal standard was developed and validated. The assay was accomplished using a mixture of acetonitrile & methanol in the volume ratio of 20:80 v/v (mobile phase B) and Ammonium acetate buffer (Mobile phase A) in gradient flow as mobile phase on an Hibar RP-18e, 250 × 4.6 mm, 5µ as chromatographic column at a flow rate of 1.300 mLmin-1, injection volume 10 µL and at a wavelength 235 nm with UV detector. Linearity of the analytical method was evaluated at a concentration range of 2.5–45.3 µg/ml for Amlodipine, 32.0–720.1 µg/ml for valsartan and 5.0–112.6 µg/ml for Hydrochlorothiazide respectively with Correlation coefficient (r) value more than 0.9997. The limit of detection (LOD) for Amlodipine, Valsartan and Hydrochlorothiazide was found to be 1.1 µg/ml, 8.0 µg/ml & 1.0 µg/ml respectively. Specificity, Method Precision, System Precision, Ruggedness, Robustness, Recovery, Stability of analytical solution, Filter paper selection study, Stress testing (Force Degradation) at various conditions were performed as per the ICH (Q2) recommendations. The chromatographic method may also be applied for simultaneous estimation of analytes in plasma and urine.