Eco-friendly based HPLC and UV-spectrophotometric methods for simultaneous estimation of Efonidipine hydrochloride Ethanolate and Chlorthalidone in their dosage form

Abstract

ObjectiveEfonidipine hydrochloride Ethanolate and Chlorthalidone combination was approved by CDSCO for Phase III clinical trial. This combination is utilized to pharmacological therapy that can effectively control hypertension situations. The present research includes an RP-HPLC and Simultaneous equation UV methods for the determination of drug combination in tablet dosage form. Furthermore, greenness assessment and statistical evaluation of developed methods. MethodsThe HPLC chromatography was performed using a gradient technique on a reversed-phase C18 column with mobile phase based and optimized depending on the polarity of the molecules. The Unesphere C18 column Agela Tech., (250 mm x 4.6 mm i.d, 5 μm,) as stationary phase and Acetonitrile: 0.2 M Potassium dihydrogen orthophosphate pH 4 (68: 32% v/v) as mobile phase. The Simultaneous equation UV method was developed and validated at 220 nm and 250 nm in methanol: distilled water (20:80, v/v). The greenness assessment tools were used to assess the ecological impact of the new UV spectrophotometric method and HPLC method. ResultsUV detection in RP-HPLC method at 220 nm for gradient elution was used to achieve chromatographic separation over the linearity 3.0–60.0 μg/mL and 10.0 - 200.0 μg/mL and for UV method 3.0–15.0 μg/mL and 10.0–50.0 μg/mL for Chlorthalidone (CLT) and Efonidipine (EFD) respectively.The value of% RSD within the limit indicated that the method is precise, accurate and% recovery shows that there is no interference from the excipients.Greenness assessment data confirmed the method's environmental friendliness in terms of solvent usage, chemical compounds, energy consumption, and trash creation. There were no spectral or chromatographic interferences from formulation excipients discovered. ConclusionThe analytical method validation parameters were found to be as per acceptance criteria. In terms of accuracy and precision, statistical testing employing an analysis of variance test did not find any significant differences between the two methods. To evaluate the greenness and whiteness of an analytical method, a reliable assessment of the health and environmental risk associated with chemical use is essential.