scholarly journals High performance liquid chromatographic method for the determination of ambroxol hydrochloride in presence of antimicrobial preservatives in oral liquid formulation

2015 ◽  
Vol 18 (1) ◽  
pp. 8-14 ◽  
Author(s):  
T Sudha ◽  
K Manthena ◽  
VR Ravikumar ◽  
V Ganesan

A simple gradient reversed phase high performance liquid chromatographic method was developed for the determination of ambroxol hydrochloride in presence of antimicrobial preservatives in oral liquid formulation. The chromatographic separation was achieved by an Inertsil C8 (250 X 4.6 mm, 5? particle size) column using gradient technique. The eluents were detected at 245 nm with photodiode array detector. The optimized mobile phase consisted of 0.1% trifluoroacetic acid as a mobile phase A and a mixture of mobile phase A and acetonitrile in the ratio of 76:24 % v/v as mobile phase B. Ambroxol hydrochloride and microbial preservatives were eluted at a flow rate of 1.0 ml/min. The method validated according to the International Conference of Harmonization (ICH) guidelines. The calibration curves were linear over the (r2 > 0.99) concentrations range from 300 to 900 ppm for ambroxol hydrochloride, 10 to 30 ppm for propyl paraben and 100 to 300 ppm for methyl paraben. The limit of detection was found to be 0.024 ppm for ambroxol hydrochloride, 0.018 ppm for propyl paraben and 0.009 ppm for methyl paraben. The percentage recoveries were found to be in the range from 99.55 to 101.1% for ambroxol hydrochloride, 100.31 to 101.46% for propyl paraben and 98.18 to 101.61% for methyl paraben. Stability indicating capability was established by forced degradation experiments. No chromatographic interference from the degradation products was found. The proposed method was highly sensitive, precision and accurate and hence successfully applied for the quantification of ambroxol active pharmaceutical ingredients (API) and preservatives content in the commercially available oral liquid formulation.Bangladesh Pharmaceutical Journal 18(1): 8-14, 2015

2017 ◽  
Vol 1 (2) ◽  
pp. 1-8
Author(s):  
Milena Cristina Ribeiro Souza Magalhães ◽  
Alisson Samuel Portes Caldeira ◽  
Hanna De Sousa Rocha Almeida ◽  
Sílvia Ligório Fialho ◽  
Armando Da Silva Cunha Junior

A reversed-phase high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of encapsulation efficiency of zidovudine in nanoparticules. The method was carried out in isocratic mode using 0.040M sodium acetate: methanol: acetonitrile: glacial acetic acid (880:100:20:2) as mobile phase, a C8 column at 25ºC and UV detection at 240 nm. The method was linear (r2 ˃ 0.99) over the range of 25.0-150.0 μg/mL, precise (RSD ˂ 5%), accurate (recovery = 100.5%), robust and selective. The validated HPLC-UV method can be successfully applied to determine the rate of zidovudine in nanoparticules.


2013 ◽  
Vol 49 (3) ◽  
pp. 521-528 ◽  
Author(s):  
Viviane Benevenuti Silva ◽  
Angel Arturo Gaona Galdos ◽  
Cintia Maria Alves Mothe ◽  
Michele Bacchi Pallastrelli ◽  
Maria Segunda Aurora Prado ◽  
...  

A simple, rapid, economical and reliable high performance liquid chromatographic method has been developed and successfully applied in simultaneous determination of ethinyl estradiol and drospirenone in coated tablets. The HPLC method was performed on a LiChroCART® 100RP column (125x4 mm i.d., 5 µm) with acetonitrile:water 50:50 (v/v) as mobile phase, pumped at a flow rate of 1.0 mL.min-1. The fluorescence detection for ethinyl estradiol was made at λex= 280 nm and λem= 310 nm and a UV detection for drospirenone was made at 200 nm. The elution time for ethinyl estradiol and drospirenone were 4.0 and 5.7 min, respectively. The method was validated in accordance to USP 34 guidelines. The proposed HPLC method presented advantages over reported methods and is suitable for quality control assays of ethinyl estradiol and drospirenone in coated tablets.


2008 ◽  
Vol 91 (1) ◽  
pp. 67-72 ◽  
Author(s):  
Juliana Sippel ◽  
Letcia L Sfair ◽  
Elfrides E S Schapoval ◽  
Martin Steppe

Abstract A new high-performance liquid chromatographic method was developed and validated for clopidogrel determination in pharmaceutical formulations. The system consisted of an ACE 5 octadecylsilane (C18; 150 4.6 mm id), 5.0 m particle size column; methanol0.1 triethylamine (75 + 25, v/v), pH 5.3, mobile phase at a flow rate of 1.2 mL/min; and a diode array detector set at 220 nm. Specificity, linearity, precision, accuracy, and robustness were the parameters evaluated. The retention time for clopidogrel was 6.8 min. To estimate specificity, an aqueous sample solution was subjected to degradation by ultraviolet light and by acid, alkaline, and oxidation media. The peaks of degradation products did not interfere with the compound signal, and there was no interference when a placebo solution was analyzed. Linearity over a concentration range of 10.0 to 90.0 g/mL was shown (correlation coefficient = 0.9998). Low values of relative standard deviation indicated the adequate intraday and interday precision. The average recovery was found as 99.16. In the robustness test, small modifications to the mobile phase composition did not affect the determination of clopidogrel. The proposed method proved to be simple, fast, and cost efficient for the intended use.


2009 ◽  
Vol 6 (2) ◽  
pp. 489-494 ◽  
Author(s):  
B. Prasanna Kumar Reddy ◽  
Y. Ramanjaneya Reddy ◽  
D. Ramachandran

A simple, sensitive and precise high performance liquid chromatographic method for the analysis of pantoprazole sodium and lansoprazole has been developed, validated and used for the determination of compounds in commercial pharmaceutical products. The compounds were well separated an isocratically on a C18column [Inertsil C18, 5μ, 150 mm x 4.6 mm] utilizing a mobile phase consisting of acetonitrile: phosphate buffer (60:40, v/v, pH 7.0) at a flow rate of 1.0 mL/min with UV detection at 230 nm. The retention time of pantoprazole sodium and lansoprazole was found to be 2.017 min and 2.538. The procedure was validated for linearity (Correlation coefficient=0.999). The study showed that reversed-phase liquid chromatography is sensitive and selective for the determination of pantoprazole sodium and lansoprazole using single mobile phase.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (05) ◽  
pp. 67-71
Author(s):  
N Dhanvijay ◽  
◽  
Vijaya Kumar Munipalli ◽  
M. Patel ◽  
S. Ghani ◽  
...  

A simple precise and rapid Reverse Phase High Performance Liquid Chromatographic method has been developed for quantitative determination of antineoplastic drug bexarotene and its capsule formulation. In this method Synchronis (C18, 25cm×4.6mm id , 5μ) column with mobile phase consisting of buffer (25mM ammonium acetate w/v solution adjusted to pH 4.0 with diluted acetic acid) and acetonitrile in the ratio of (20: 80 v/v) in an isocratic mode was used. The detection was carried out at 262 nm and 20.0 μL injection volume was selected, with the flow rate of 1.0 mL/min being used. The linearity range of bexarotene shows concentration between 5-200 μg/mL. Retention time of bexarotene was found to be 12.58 minutes. Mobile phase itself was used as a diluent. The method was validated as per ICH guidelines and is simple, fast, accurate, precise and can be applied for routine quality control analysis of bexarotene in its formulation.


1984 ◽  
Vol 30 (6) ◽  
pp. 908-910 ◽  
Author(s):  
T Annesley ◽  
K Wilkerson ◽  
K Matz ◽  
D Giacherio

Abstract We describe a "high-performance" liquid-chromatographic method for simultaneously measuring various penicillin and cephalosporin antibiotics. After extraction from serum, which in general is quantitative, the drugs are separated by use of a "Bondapak phenyl" column and a gradient mobile phase. For these drugs retention times depend on the pH of the mobile phase; we present retention times under selected pH conditions.


2005 ◽  
Vol 70 (12) ◽  
pp. 1451-1460 ◽  
Author(s):  
Dragica Zendelovska ◽  
Trajce Stafilov

Ahigh-performance liquid chromatographicmethod for the determination of ofloxacin and lomefloxacin in human plasma has been developed and validated. The effect of organic modifiers on the retention of the investigated drugs was investigated. A simple isocratic chromatographic assay with UV-detection at 280nm was performed on a Hibar Lichrospher 100 RP 8 column (250x4.6mm 5?m. Merck, Germany) using a mixture of acetonitrile and 0.5 % triethylamine in water (pH adjusted to 2.5 with H3PO4) (15:85, V/V) as the mobile phase at flow rate of 1.2 mL min-1. The calibration curves were linear in the concentration ragne of 0.5-6.0?g mL-1 for ofloxacin and 0.2-4.5 ?g mL-1 for lomefloxacin.


1983 ◽  
Vol 29 (5) ◽  
pp. 851-853 ◽  
Author(s):  
T Okuda ◽  
T Oie ◽  
M Nishida

Abstract We describe the adaptation of a "high-performance" liquid chromatographic method for determination of creatinine in serum and urine. The proposed method is simple, rapid, precise, and accurate. The retention time for creatinine can be varied simply by changing the KH2PO4 concentration in the mobile phase: acetonitrile/aqueous KH2PO4 (1/4 by vol). Within-day precision (CV) was 1.2-3.6% in serum chromatographed with an internal standard, and 2.3-2.8% in serum when an external standard was used. Between-day precision (CV) was 1.3-2.1% in serum and 1.3-2.7% in urine (with an external standard). Analytical recoveries of creatinine added to serum were 94-100% for the method with an internal standard, 95-103% with an external standard.


2011 ◽  
Vol 8 (s1) ◽  
pp. S372-S376 ◽  
Author(s):  
Xiaoying Zhou ◽  
Haoke Zhang ◽  
Liang Ge ◽  
Haiyan Gong ◽  
Shuge Tian

A simple, precise, rapid and accurate, binary-phase high performance liquid chromatographic method has been developed for the determination of arctiin and arctigenin contents in theArctium tomentosumMill. with short run time. Chromatographic separation was achieved by using HPLC system, consisting of a Shimadzu LC-6AD and Kromasil C18column (250×4.6 mm, 5 μm, with pre-column), the mobile phase consists of methanol and water (55: 45). Detection wavelength was 280 nm. The speed of flow was 1.0 mL/min. The specimen handing quantity was 10 μL. The arctiin’s linearity range was 1.575∼4.725 μg (r=0.9995). The arctigenin’s linearity range was 0.613, 3.063 μg (r = 0.9998) and the linear relationship was accurate. The average recovery (n=5) of arctiin and arctigenin were 101.55% (RSD=2.23%) 101.63% (RSD =1.49 %) respectively. The contents of arctiin and arctigenin inArctium tomentosumMill. were 10.69 mg/g and 0.15 mg/g, respectively. Therefore, the developed HPLC method can be applied to bothin vitrostudies of arctiin and arctigenin formulations as well as drug estimation in biological samples.


Author(s):  
CAROLINE GRACE A ◽  
PRABHA T ◽  
SIVAKUMAR T

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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