Validated stability-indicating RP-HPLC method for simultaneous estimation of cilnidipine and chlorthalidone in tablet dosage form (original) (raw)
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Journal of Drug Delivery and Therapeutics
A simple precise and economical reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Cilnidipine (CDP), Atenolol (ATL) and Chlorthalidone (CTD).The chromatographic separation was achieved by using Hypersil- keystone C18 (4.6 x 250mm, 5μm) under isocratic conditions The mobile phase consisted of methanol and triple distilled water (80/20, v/v) having pH 7 with a flow rate of 1.0 mL/min. The eluents were monitored at 225 nm for simultaneous measurement.The selected chromatographic conditions were found to effectively separate CDP (Rt: 3.25 min), ATL (Rt: 5.366 min) and CTD (Rt: 9.025 min) having good resolution. The developed method was validated for linearity, accuracy, precision, LOD, LOQ, robustness and for system suitability parameters as per ICH guidelines. In this study, an excellent linearity was obtained with r2 = 0.999, r² = 0.999, r² = 1, for CDP, ATL and CTD respectively. The developed chromatograph...
Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Cilnidipine
2020
Cilnidipine is one of the dihydropyridine calcium antagonists. It was created combinedly by Fuji Viscera Pharmaceutical Company, Ajinomoto and Japan and was approved in the year 1995. Cilnidipine acts on N-type calcium channel where exist the end of sympathetic nerve in addition to common L-type calcium channel like that of other calcium antagonists. China, Japan, India, Korea and several other countries approved this drug. The objective of the method validation is to demonstrate whether the method was suited for the intended purpose. The method was validated as per the ICH guidelines. The method was validated for linearity, precision (repeatability, intermediate precision), accuracy, specificity, robustness, limit of detection and limit of quantification. Cosmosil (4.6 X 250mm, 5 μ) column was used for separation. The selected wavelength for Cilnidipine was 241 nm. The mobile phase consists Methanol: Potassium dihydrogen phosphate buffer (50:50). Flow rate was delivered at 1.0 mL/m...
2013
A new simple, precise, accurate and selective RP-HPLC method has been developed and validated for simultaneous estimation of cinnarizine (CIN) and domperidone (DOM) in tablet dosage form. The method was carried out on a C-18 (250mm × 4.6mm i.d, 5μm) column with a mobile phase consisting of methanol and acetonitrile in the ratio (70:30 v/v) and flow rate of 1.0 mL min. The detection was carried out at 270 nm. The retention time for CIN and DOM were found to be 3.389 and 4.793 min respectively. The CIN and DOM followed linearity in the concentration range of 40-160 μg mL and 45105 μg mL with r= 0.999. The amount of both drugs estimated by the proposed method was found to be in good agreement with label claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The developed method can be used for routine analysis of titled drugs in combination in the tablet formulations.
INDIAN DRUGS, 2014
Candesartan Cilexetil is an antihypertensive agent currently available in combination with Hydrochlorothiazide. However, it has been proven by research that half dose of Chlorthalidone is equipotent to the dose of Hydrochlorothiazide in similar combination with Candesartan Cilexetil. At present there is no Liquid Chromatographic (LC) method available for the simultaneous estimation of Candesartan Cilexetil and Chlorthalidone in pharmaceutical dosage form. A simple, rapid, reliable and robust reversed phase ultra-performance liquid Chromatography (RP-UPLC) method was developed as per International Conference on Harmonization (ICH) guidelines. The best separation was achieved in less than 5 minutes on a 50 × 2.1 mm, 2.2 µm particle size Dionex C18 column with the gradient mobile phase 5 mM, 6.2 ± 0.5 pH ammonium acetate buffer - acetonitrile at a flow rate of 0.5 mL/min at 215nm. The detector response was linear in the range of 10-200 ppm of these drugs. LOD obtained was 3.04 ppm for ...
The study's objective is to provide a rapid, simple, accurate, and cost-effective RP-HPLC assay technique for the simultaneous quantification of domperidone and cinnarizine in pharmaceutical bulk. Domperidone and cinnarizine in bulk have been successfully separated using this approach. Separation was carried out at 226 nm on a C18 SunfireTM (5 m, 250 mm 4.6 mm) analytical column using an Orthophosphoric acid and acetonitrile (60:40) mobile phase operating in isocratic elution mode at a flow rate of 1.0 ml/min. Domperidone had a retention time of 2.52 minutes, whereas Cinnarizine's was 5.18 minutes. PDA detection at 226 nm based on peak area with linear calibration curve in concentration ranges of 0-5 g/ml (0.9999) and 0-25 g/ml (0.9996) allowed for accurate quantitation of Domperidone and Cinnarizine, respectively. Domperidone and cinnarizine
ijpsr.com
A simple precise and economical reverse phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Cilnidipine (CDP), Atenolol (ATL) and Chlorthalidone (CTD).The chromatographic separation was achieved by using Hypersil-keystone C18 (4.6 x 250mm, 5μm) under isocratic conditions The mobile phase consisted of methanol and triple distilled water (80/20, v/v) having pH 7 with a flow rate of 1.0 mL/min. The eluents were monitored at 225 nm for simultaneous measurement.The selected chromatographic conditions were found to effectively separate CDP (Rt: 3.25 min), ATL (Rt: 5.366 min) and CTD (Rt: 9.025 min) having good resolution. The developed method was validated for linearity, accuracy, precision, LOD, LOQ, robustness and for system suitability parameters as per ICH guidelines. In this study, an excellent linearity was obtained with r 2 = 0.999, r² = 0.999, r² = 1, for CDP, ATL and CTD respectively. The developed chromatographic method proved to be simple, precise, accurate, robust and reproducible Thus, this method would be employed for routine simultaneous quantification of CDP, ATL and CTD in bulk form or tablet dosage form.