scholarly journals Enantiomeric separation of Midodrine hydrochloride in bulk and pharma-ceutical dosage form by chiral HPLC

2019 ◽  
Vol 10 (3) ◽  
pp. 1608-1611
Author(s):  
Jenifer Ashwini S ◽  
Narenderan ST ◽  
Meyyanathan SN ◽  
Babu B ◽  
Gowramma B
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Enantiomeric Separation ◽  
Hplc Method ◽  
Ammonium Bicarbonate ◽  
Chiral Hplc ◽  
Column Temperature ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, sensitive chiral liquid chromatographic method was developed for the separation and quantification of enantiomers Midodrine. A chiral PAK IG-3 (150 x 4.6 mm) 3µm column was used for the separation of the enantiomers. The mobile phase consists of 10 mM ammonium bicarbonate in water and acetonitrile in the ratio of 95:5, v/v with a flow rate of 0.7 ml/min. The detection was done at 290 nm with column temperature maintained at 40°C. The method linear ranged between 10 – 110 μg/ml and 5 – 100 μg/ml for (+) and (-) Midodrine enantiomers.  The recovery of the method was found to be in the range of 99.1 to 101.2 %. The detection limit for the (+) and (-) enantiomers was found to be 4 μg/ml and 1 μg/ml, respectively. A simple validated chiral HPLC method with reverse elusion is described for the separation and quantification of the enantiomers of Midodrine in bulk and formulation.

A Green Liquid Chromatographic Method For The Simultaneous Determination of Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride and Propyphenazone

2019 ◽  
Vol 15 (6) ◽  
pp. 635-641
Author(s):  
Nadia M. Mostafa ◽  
Ghada M. Elsayed ◽  
Nagiba Y. Hassan ◽  
Dina A. El Mously
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Green Analytical Chemistry ◽  
Chlorpheniramine Maleate ◽  
Accuracy And Precision ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

Background:The concept of green analytical chemistry prevails due to the growing environmental pollution.Objective:Our attempts are to develop simple and eco-friendly method which is non-harmful to the environment by producing minimal waste. In this context, a green liquid chromatographic method was applied for the simultaneous determination of chlorpheniramine maleate, pseudoephedrine hydrochloride and propyphenazone in their combined dosage form.Methods:Separation was carried out using X select HSS RP C18 analytical column (250 × 4.6 mm, 5μm) using methanol - 0.02 M phosphate buffer pH 3 - triethylamine (60:40: 0.1, by volume) as a mobile phase. The separated peaks were detected at 215 nm at a flow rate 1.0 mL/min.Results:Quantification was done over the concentration ranges of 1-25 µg/mL for chlorpheniramine maleate, 5-35 µg/mL for pseudoephedrine hydrochloride and 10-120 µg/mL for propyphenazone. The suggested method was validated with regard to linearity, accuracy and precision according to the International Conference on Harmonization guidelines with good results.Conclusion:It could be used as a safer alternative for routine analysis of the mentioned drugs in quality control laboratories.

scholarly journals BIOEQUIVALENCE STUDIES OF MARKETED CLOZAPINE TABLETS BY USING OPTIMIZED VALIDATED LIQUID CHROMATOGRAPHIC METHOD

2018 ◽  
Vol 10 (3) ◽  
pp. 47
Author(s):  
Udayasree Konikuru ◽  
Rajavel P. ◽  
Vijitha S.
Keyword(s):  
Mobile Phase ◽  
Chromatographic Method ◽  
Accurate Method ◽  
Stability Studies ◽  
Column Temperature ◽  
Rp Hplc ◽  
Liquid Chromatographic Method ◽  
Dissolution Apparatus ◽  
Liquid Chromatographic ◽  
Interday Precision

Objective: A simple, selective, precise and accurate method was developed for the estimation of Clozapine by RP-HPLC technique.Methods: Chromatographic conditions used are stationary phase, Phenomenex BDS (150 mm x 4.6 mm, 5µ), Mobile phase was methanol and water in (80:20) ratio and flow rate was maintained at 1.0 ml/min, column temperature was set at 25 °C, detection wavelength was 240 nm, and diluent was mobile phase. These conditions were finalized for the optimized method.Results: Linearity study was carried out between 10-60 µg/ml, the R2 value was found to be as 0.995. Precision was found to be as follows for system precision 1.052, method precision 1.662, and intraday precision 1.02 and for interday precision 0.93. The % Recovery was found to be 98.60%. LOD and LOQ were found to be 2.7 µg/ml and 8.4 µg/ml respectively. By using the above method assay of the marketed formulation was carried out and the % purity was found to be 99.28 %. Stability studies of Clozapine were done, in all conditions degradation was found to be within the acceptable range.Conclusion: The current validated method was finally applied in bioequivalence studies of four different brands of Clozapine by using dissolution apparatus and percentage drug release was found to be 99.48%, it was within the acceptable limit (NLT 85 %) as per USP.

scholarly journals Development of a chiral RP-HPLC method for identification of stereomers of newly synthesized xanthine-based hydrazide-hydrazone compound

Pharmacia ◽  
2019 ◽  
Vol 66 (1) ◽  
pp. 1-5 ◽  
Author(s):  
Lily Peikova ◽  
Diana Tzankova ◽  
Alexandrina Dineva ◽  
Maya Georgieva ◽  
Alexander Zlatkov
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Enantiomeric Separation ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Phase System ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic ◽  
Hydrazone Compound

A reversed phase enantio selective high performance liquid chromatographic method was developed for enantiomeric separation of 2-(1,3-dimethyl-2,6-dioxo-2,3-dihydro-1H-purine-7(6H)-yl)-N'-(3-fluorobenzylidene)-propanehydrazide isomers. The enantiomers of 2-(1,3-dimethyl-2,6-dioxo-2,3-dihydro-1H-purine-7(6H)-yl)-N'-(3-fluorobenzylidene)propanehydra-zide were resolved on a ACEÒEquivalenceTM С18 (250 × 4.6 mm, 5 μm) column using a mobile phase system containing methanol, water, phosphate buffer рН 7.4 (50:46:4 v/v/v). The resolution between enantiomers was found to be more than 2.0. The sample solution and mobile phase were found to be stable for at least 48 h. The final optimized method was successfully applied to separate the (R)- and the (S)-enantiomers of 2-(1,3-dimethyl-2,6-dioxo-2,3-dihydro-1H-purine-7(6H)-yl)-N'-(3-fluorobenzylidene)-propanehydrazide and was proven to be reproducible and accurate.

Simultaneous assay of Mupirocin and Metronidazole in formulations using Reverse Phase-High Performance Liquid Chromatography

2016 ◽  
Vol 5 (12) ◽  
pp. 5151
Author(s):  
Sivannarayana P.* ◽  
K. Rambabu
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Pharmacokinetic Studies ◽  
Reverse Phase ◽  
Column Temperature ◽  
Ich Guidelines ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A new reverse phase-high performance liquid chromatographic method for the assay of mupirocin and metronidazole in formulation has been developed and validated as per ICH guidelines. The present study was carried on Water’s X-bridge C-18 column (4.6 x150mm, 5μ particle size) with mobile phase containing a mixture phosphate buffer (pH 2.5) and acetonitrile in the ratio of 70:30, %v/v at a flow rate of 1.0ml/min with UV detection at 220nm in ambient column temperature. The retention times for mupirocin and metronidazole were found to be 2.153 and 3.157 min respectively with linearity in the concentration range of 20-60μg/mL for mupirocin and 10-30μg/mL for metronidazole respectively. The developed reverse phase-high performance liquid chromatographic method was found to be best suitable for pharmacokinetic studies of these mentioned drugs in formulations.

scholarly journals Development and Validation of Liquid Chromatographic Method for Estimation of Ibuprofen and Famotidine in Combined Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Dimal A. Shah ◽  
Dixita J. Suthar ◽  
Sunil L. Baldania ◽  
Usman K. Chhalotiya ◽  
Kashyap K. Bhatt
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Reversed Phase ◽  
Assay Method ◽  
Liquid Chromatographic Method ◽  
Phase Liquid ◽  
Development And Validation ◽  
Liquid Chromatographic

An isocratic, reversed phase-liquid-chromatographic assay method was developed for the quantitative determination of ibuprofen and famotidine in combined-dosage form. A Brownlee C18, 5 μm column with mobile phase containing water : methanol : acetonitrile (30 : 60 : 10, v/v/v) was used. The flow rate was 1.0 mL/min, and effluents were monitored at 264 nm. The retention times of ibuprofen and famotidine were 4.9 min and 6.8 min, respectively. The linearity for ibuprofen and famotidine was in the range of 2–20 μg/mL and 0.1–10 μg/mL, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity, and robustness. The method was successfully applied to the estimation of ibuprofen and famotidine in combined dosage form.

scholarly journals Stability Indicating RP-HPLC Assessment and Stability Testing of Tazarotene and Halobetasol in Lotion Formulation

2020 ◽  
Vol 32 (6) ◽  
pp. 1456-1462
Author(s):  
V.L.N. Balaji Gupta Tiruveedhi ◽  
Venkateswara Rao Battula ◽  
Kishore Babu Bonige
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Degradation Products ◽  
Isocratic Elution ◽  
Limit Values ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A novel liquid chromatographic method was established and validated for the quantification of tazarotene and halobetasol in the presence of degradation products obtained during stress conditions. The liquid chromatographic method was based on isocratic elution on Knauer Eurospher II C18 (5 μm particle size, 250 mm × 4.5 mm) column using a mobile phase consisting of methanol, acetonitrile and 0.5 mM perchloric acid (40:45:15 v/v/v) mixture at flow rate of 0.9 mL/min. Quantization of tazarotene and halobetasol was done with UV detection at 234 nm. The method validity was assessed in agreement with the recommendations of the International Conference on Harmonization. Linearity, accuracy and precision were satisfactory over the concentration ranges of 2.25-13.5 and 0.5-3.0 μg/mL for tazarotene and halobetasol, respectively. Detection limit values of 0.006 μg/mL and 0.01 μg/mL were found for halobetsol and tazarotene, respectively, while the quantization limit values of 0.02 μg/mL and 0.033 μg/mL were found for halobetsol and tazarotene, respectively. The developed method is appropriate for routine analysis and quality control of tazarotene and halobetasol combination in lotion dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DAPAGLIFLOZIN AND ITS IMPURITIES IN TABLET DOSAGE FORM

2019 ◽  
pp. 447-453
Author(s):  
CAROLINE GRACE A ◽  
PRABHA T ◽  
SIVAKUMAR T
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Good Precision ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: The aim of the present work is the development of new, sensitive, specific, and accurate high-performance liquid chromatographic method for the separation and determination of dapagliflozin and its impurities in tablet dosage form. Methods: The chromatographic separation of drug and its impurities was achieved using Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μ) with mobile phase consisted of mobile phase-A (Buffer pH 6.5) and mobile phase-B (acetonitrile:water 90:10) by gradient program at a flow rate of 1 mL/min with ultraviolet detection at 245 nm. Results: Dapagliflozin and its impurities A, B, C, D, E, and impurity-F were successfully eluted at the retention time of 16.95, 2.72, 7.82, 10.58, 21.11, 30.37, and 34.36 min, respectively, with good resolution. The method was validated according to the international conference on harmonization guidelines. The validation results showed good precision, accuracy, linearity, specificity, sensitivity, and robustness. Conclusion: Successful separation and determination of dapagliflozin and its six impurities were achieved by the proposed method. The developed method can be applied for the routine analysis of dapagliflozin and its impurities in pharmaceutical formulations.

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