scholarly journals Assessment of the greenness of micellar HPLC method for rapid separation and simultaneous estimation of chlorpheniramine maleate in presence of some co-administered drugs in three pharmaceutical dosage forms using single run

Author(s):  
Zeinab Adel Nasr ◽  
Marwa M. Soliman ◽  
Ekram H. Mohamed ◽  
Fatma A. Fouad

AbstractSustainable chemistry established one of kind standards to maintain protection of environment through using safer mobile phase composition and/or lower solvent consumption. A fast green micellar HPLC method was developed and applied for the first time aiming at simultaneous determination of chlorpheniramine maleate, one of the most widely used antihistamine in combination with levochlopersatine fenodizoate or dextromethorphan hydrobromide or dexamethasone, in their pure forms, laboratory prepared mixtures and pharmaceutical dosage forms used in alleviating the symptoms of cough resulting from common colds and allergy. The separation was achieved on Kinetex C18 column (100 mm × 4.6 mm i.d., 2.6-μm particle size) using micellar aqueous mobile phase consisting of (30 mM sodium dodecyl sulfate and 50 mM sodium dihydrogen phosphate, pH 5) and ethanol (85:15) with UV detection at 230 nm. The four drugs were successfully separated using isocratic elution in a single run not exceeding 7 min. According to ICH guidelines, the method was confirmed to be linear, accurate and precise over the concentration ranges of 5–60 μg mL−1 for chlorpheniramine maleate, 10–100 μg mL−1 for levocloperastine fenodizoate and dextromethorphan hydrobromide and 5–30 μg mL−1 for dexamethasone. In addition, the greenness of the developed method was assessed using two different tools indicating their least hazardous effect on the environment.

2016 ◽  
Vol 2 (2) ◽  
pp. 89 ◽  
Author(s):  
S Ashutosh Kumar ◽  
Manidipa Debnath ◽  
D. Vimala

The present study aimed to develop and validate the simultaneous estimation of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr in tablet dosage forms. A gradient reversed phase high-performance liquid chromatographic (HPLC) method with ultraviolet detection at 220 nm has been developed for the simulataneous determination of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr in pharmaceutical dosage forms (Syrup). Good chromatographic separation was achieved by using a stainless steel analytical column, the Hypersil BDS C8 column (4.6 X 250 mm; 5 μm). The system was operated at 25 ± 2°C using a mobile phase consisted of HPLC grade water (composed of TEA and 1-octane sulfonic acid sodium salt) (pH adjusted to 3.2 using orthophosphoric acid) and acetonitrile, mixed at gradient mode, manitained flow rate at 1.0 mL/minute. The slope, intercept, and correlation coefficient were found to be y = 34306x - 11042 (r2= 0.999) for phenylephrine HCl, y = 35874x - 13101 (r2= 0.999) for chlorpheniramine maleate and dextromethorphan HBr y = 25516x - 26579 (r2 = 0.999), respectively. The proposed method was validated for its specificity, linearity, accuracy, and precision. The method was found to be suitable for the quality control of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr simultaneously in a bulk drug samples as well as in a formulations.


2013 ◽  
Vol 11 (2) ◽  
pp. 157-163
Author(s):  
Md Akteruzzaman ◽  
Asma Rahman ◽  
Md Zakir Sultan ◽  
Farhana Islam ◽  
Md Abdus Salam ◽  
...  

The objective of this study was to develop a simple, efficient, precise and accurate reversed phase HPLC (RP-HPLC) method for simultaneous determination of metformin in combination with rosiglitazone in newly formulated tablets. The combination of these drugs are commonly used and prescribed as anti-diabetic drugs in Bangladesh. The method has been developed by using the mobile phase comprising of sodium dihydrogen phosphate (NaH2PO4) buffer (pH 3.5) and acetonitrile (60:40, v/v) at a flow rate of 0.7 ml/min over C18 bonded silica column (ODS) (250 x 4.6 mm, 5 ?) at ambient temperature. The effluents were monitored at 230 nm and retention times were found to be 3.35 min and 11.95 min for metformin and rosiglitazone, respectively. Calibration curves were determined with a range from 0.03125 to 0.50 ?mole/ml of standards and the regression coefficients (r2) were found as 0.999 for metformin and 1.0 for rosiglitazone. The assay was validated for the accuracy, precision etc. according to ICH, USP and FDA guidelines. The proposed method can be useful in routine analysis for quantitative determination of metformin hydrochloride and rosiglitazone in pharmaceutical dosage forms. DOI: http://dx.doi.org/10.3329/dujps.v11i2.14574 Dhaka Univ. J. Pharm. Sci. 11(2): 157-163, 2012 (December)


Author(s):  
Choudhary B. ◽  
Goyal A. ◽  
Khokra S. L. ◽  
Kaushik D.

A simple, accurate and reproducible HPLC method have been developed for simultaneous estimation of Diclofenac sodium and rabeprazole from their tablets formulations. A phenomenex C18 (Luna) column of length 250×7.5 mm with particle size of the stationary phase 5 μm and S mobile phase potassium dihydrogen phosphate buffer (pH adjusted to 7.5 with 1 M sodium hydroxide) and acetonitrile in the ratio 60: 40 were used in this study. Retention time was found to be 9.20 min and 6.40 min for Rabeprazole and diclofenac sodium respectively. While that for internal standard as domperidone was 11.87 min at a flow rate of 2ml / min. Linearity was found in the concentration range of 10-50 μg /ml for both the drugs in this method. The results of analysis have been validated statistically and also by recovery studies.


2017 ◽  
Vol 36 (2) ◽  
pp. 201 ◽  
Author(s):  
Tanja Bakovska Stoimenova ◽  
Marjan Piponski ◽  
Gordana Trendovska Serafimovska ◽  
Marina Stefova

A fast, simple, cost-effective and robust chromatographic method was developed and validated for determination of the antihypertensive drug lisinopril dihydrate in tablets under routine operational conditions, without ion-pair reagents, high column temperatures and an acidic mobile phase. Taking into consideration all four different pKa values of lisinopril, the separation was optimized using the C18 column (end-capped, 150 mm × 4.6 mm 5 µm) and a mobile phase composed of methanol and ammonium (or potassium) dihydrogen phosphate buffer (pH 7.2) with a flow rate of 1.1 ml/min, UV detection at 214 nm and a temperature of 40 °C. These optimized conditions led to the production of a single and symmetrical peak for lisinopril. This mobile phase is suitable for different HPLC columns, which makes it appropriate for industrial quality control laboratories. The developed method was validated, showing excellent validation results and the possibility to be implemented for the determination of lisinopril in combined dosage forms with other active substances.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (02) ◽  
pp. 50-56
Author(s):  
S. Vadrevu ◽  
◽  
K. Govindarao

The developed RP-HPLC method allows rapid and precise determinations of escitalopram and etizolam in bulk and pharmaceutical dosage forms. The objective of the proposed method was to develop a simple and accurate method for the determination of escitalopram and etizolam by RP-HPLC method in pharmaceutical dosage forms & its stability indicative studies. A series of mobile phases were tried; among the various mobile phases , potassium dihydrogen phosphate buffer and dipotassium hydrogen phosphate 0.02 M, pH 3.0 : acetonitrile (20:80) is an ideal mobile phase, since it gave a good resolution and peak shapes with perfect optimization. The flow rate was optimized at less than 2 mL/min. The linearity and correlation coefficient of escitalopram and etizolam at 0-45μg/mL and 0-75μg/mL was found to be 0.998 & 0.998, respectively. The LOD was found to be 0.1 mg/mL and 0.3 mg/mL and LOQ was found to be 0.15 mg/mL and 0.45 mg/mL for escitalopram and etizolam, respectively, which represents that sensitivity of the method is high. The method was known to be accurate with the assay method. The % assay was found to be 100 % and 98%. The developed method showed a good accuracy and precision. The % RSD is for escitalopram and etizolam was found to be 1.50 and 1.22. This method shows good reproducibility of the results. Furthermore, this method was simple, sensitive, and accurate. Hence, the chromatographic method developed for escitalopram & eizolam can be effectively applied for routine analysis.


2009 ◽  
Vol 6 (4) ◽  
pp. 1091-1102 ◽  
Author(s):  
Vanita Somasekhar ◽  
Dannana Gowrisankar ◽  
H. N. Shivakumar

The objective of the current study was to develop a simple, accurate, precise and rapid reversed-phase HPLC method and subsequent validation as per ICH guidelines for the determination of venlafaxine hydrochloride in pharmaceutical dosage forms. The proposed RP-HPLC method utilizes a 5 μm Varian®Microsorb-MV 100 C18column (250 mmx4.6 mm) at ambient temperature. A 23factorial design consisting of 3 factors at 2 levels was set up to standardize the chromatographic conditions. A numerical optimization technique employing the desirability approach was used to locate the optimum chromatographic conditions. The optimum mobile phase consisted of acetonitrile, 0.04 M potassium dihydrogen phosphate buffer and methanol (45:25:30, v/v), with pH adjusted to 5.5 using 10% phosphoric acid solution. The mobile phase was delivered isocratically at a flow rate of 1 mL/min with UV detection at 224 nm. The calibration plots constructed using the optimized chromatographic conditions displayed good linear relationship in the concentration range of 1-50 μg/mL with r=0.9992. The method was validated for precision, accuracy, robustness and recovery. The minimum detectable and minimum quantifiable amounts were found to be 0.568 and 1.72 μg/mL, respectively and the method was found to be reproducible from the statistical data generated. Venlafaxine hydrochloride was eluted at 3.43 min


2006 ◽  
Vol 3 (1) ◽  
pp. 60-64 ◽  
Author(s):  
P. Venkata Reddy ◽  
B. Sudha Rani ◽  
G. Srinu Babu ◽  
J. V. L. N. Seshagiri Rao

A reverse phase HPLC method is developed for the determination of Raloxifene in pharmaceutical dosage forms. Chromatography was carried out on an inertsil C18 column using a mixture of acetonitrile and phosphate buffer (30:70 v/v) as the mobile phase at a flow rate of 1 mL/min. Detection was carried out at 290 nm .The retention time of the drug was 10.609 min. The method produced linear responses in the concentration range of 0.5-200 µg/mL of Raloxifene. The method was found to be applicable for determination of the drug in tablets.


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