Stability indicating HPTLC method for quantitative estimation of manidipine sihydrochloride API

Abstract

A simple, selective, precise and stability indicating high performance thin layer chromatographic method has been established and validated for analysis of manidipine hydrochloride in bulk. The compound was analyzed on aluminium backed silica gel 60 F254 plates with methanol:water, 8.5:1.5 (v:v) as mobile phase. The system was found to give compact spots for manidipine dihydrochloride (RF=0.75). Densitometric analysis was performed at 230 nm. Regression analysis data for the calibration plot indicated good linear relationships between response and concentration over the range of 500-3000 ng/spot. The correlation coefficient, r 2 was 0.998. The values of slope and intercept of the calibration plot were 2785.5 and 62.314, respectively. The method was validated for precision, recovery and robustness. The limits of detection and quantification were 20 and 50 ng, respectively. Manidipine dihydrochloride was subjected to acid, base, peroxide and sunlight induced degradation. In stability test the drug was susceptible to acid and base hydrolysis, oxidation and photodegradation. Statistical analysis proved that the method is repeatable, selective and accurate for manidipine. Because the method could effectively separate the drug from their degradation products, it can be used as a stability indicating method. HPTLC Manidipine dihydrochloride ValidationStability studies Stress degradation studies Limit of detection

Nano-Iron Oxide Supported on the Printed Electrode for Voltammetric Determination of Manidipine on a Very Small Sample in Different Media: Analytical and Clinical Purposes

“…Accuracy.-To demonstrate the suggested method accuracy, the results of MANI in the pharmaceutical form evaluated by the proposed technique were compared with those found in the valid reported HPLC technique. 55 The calculated statistical evaluation of the results obtained by the studied voltammetric technique and those that were found by the reported method using Student's t-test and the proportion of variance F-test showed that there was no significant variance for the two.…”

Quantitative Spectroscopic Investigation of Losartan Potassium in Bulk and Pharmaceutical Dosage by Visible Spectrophotometry

“…It has been authorized in Indian, British and United State Pharmacopoeia(IP,BP, and USP). LSP was well studied by titration and chromatographic methods in USP,IP, and BP 3-5 . According to literature, there are few physic-chemical methods for the determining LSP in pharmaceutical formulations like UV [6][7][8][9][10][11][12] , RPHPLC [13][14][15][16][17] , HPLC [18][19][20][21] , HPTLC [22][23] , capillary electrophoresis and supercritical fluid chromatography [24][25] , Cathodic Adsorptive stripping voltammetry 26 . The functional groups of LSP are not well exploited to design a suitable spectroscopic method for the determination of LSP.…”