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.

开发并验证了一种简单，特异，精确，准确，线性，坚固，耐用的高效液相色谱分析方法，用于同时测定以吡格列酮为常见内标的药物片剂中氨氯地平，缬沙坦和氢氯噻嗪的含量。在250 bar的Hibar RP-18e上，使用体积比为20:80 v / v的乙腈和甲醇的混合物（流动相B）和乙酸铵缓冲液（流动相A）作为流动相完成测定。 ×4.6 mm，5 µ作为色谱柱，流速1.300 mLmin-1，进样量10 µL，使用紫外检测器，波长235 nm。氨氯地平的浓度范围为2.5–45.3 µg / ml，缬沙坦的浓度范围为32.0–720.1 µg / ml，而5.0–112的浓度范围则评估了分析方法的线性。氢氯噻嗪的浓度分别为6 µg / ml，相关系数（r）值大于0.9997。氨氯地平，缬沙坦和氢氯噻嗪的检出限（LOD）分别为1.1 µg / ml，8.0 µg / ml和1.0 µg / ml。根据ICH（Q2）的建议，在各种条件下进行了特异性，方法精密度，系统精密度，坚固性，稳健性，回收率，分析溶液的稳定性，滤纸选择研究，压力测试（强制降解）。色谱方法还可用于同时估算血浆和尿液中的分析物。根据ICH（Q2）的建议，在各种条件下进行了特异性，方法精密度，系统精密度，坚固性，稳健性，回收率，分析溶液的稳定性，滤纸选择研究，压力测试（强制降解）。色谱方法还可用于同时估算血浆和尿液中的分析物。根据ICH（Q2）的建议，在各种条件下进行了特异性，方法精密度，系统精密度，坚固性，稳健性，回收率，分析溶液的稳定性，滤纸选择研究，压力测试（强制降解）。色谱方法还可用于同时估算血浆和尿液中的分析物。