Validated UV and RP-HPLC Method Development for the Estimation of Anti-Hypertensive Drug in Marketed Formulation
Vivek Jain1, Sakshi Viswakarma*1, Geeta Parkhe2
ABSTRACT
Lacidipine (LAC) is a calcium channel blocker used in treatment of hypertension. In present study a simple, sensitive and accurate isocratic reverse phase high performance liquid chromatography (RP-HPLC) and UV spectrophotometric method was developed for determination of lacidipine in tablets formulation. Different analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines. The RP-HPLC method was developed by the isocratic technique on a reversed-phase Thermo C18 (250 × 4.6 mm, 5µm) column with mobile phase consisting of methanol: water (80:20v/v) at flow rate of 1.0 ml/min. The retention time for LAC was 3.778+0.3min. The UV spectrophotometric determinations were performed at 240 nm using methanol as a solvent. The linearity range for LAC was 5-25 ?g/ml for both HPLC and UV method. The linearity of the calibration curves for each analyte in the desired concentration range was good (r2 >0.999) by both the HPLC and UV methods. The method showed good reproducibility and recovery with percent relative standard deviation less than 2%. Moreover, the accuracy and precision obtained with HPLC co-related well with the UV method which implied that UV spectroscopy can be a cheap, reliable and less time consuming alternative for chromatographic analysis. The proposed methods are highly sensitive, precise and accurate and hence successfully applied for determining the assay and in vitro dissolution of a marketed formulation.
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