Spectrophotometric and chromatographic method development and validation for determination of some antihypertensive drugs in their combined dosage form

Abstract

Hypertension is the most common disorder, affecting 1.13 billion individuals globally. Antihypertensive formulations are considered to be more effective for the management of hypertension. In recent days, different formulations are available which are used for management of hypertension in single and combined dosage forms. So, present investigation was undertaken with a view to develop different analytical methods for simultaneous estimation of antihypertensive drugs in formulations so as we can measure them in very precise manner. Three new combinations of antihypertensive drugs were used for the research work are Hydrochlorothiazide and Methyldopa, Torsemide and Eplerenone and Amlodipine Besylate and Candesartan Cilexetil. Most sensitive RP-HPLC method by applying QbD concept was developed. HPTLC Method was developed by using fewer amounts of solvents and with good resolution of peaks which is very helpful for early phase of formulation development. Chemometric Methods (CLS and ILS) were developed which are capable to determine constituents in presence of matrix very accurately. UV spectrophotometric Methods (Q- Absorbance Ratio method and First order derivative) were developed as they are very much convenient and less time consuming and also possible for small scale industries. All developed methods were validated according to ICH guideline and statistical comparison was done by ONE WAY ANOVA method. Developed Analytical methods can be widely used in recent era as this is a prime requirement for dossier submission and commercial acceptability. newline