scholarly journals Simultaneous estimation of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr in a pharmaceutical (syrup) formulations by RP-HPLC using PDA detector

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.

Author(s):  
K Tirumala ◽  
CH.V.S Gautam ◽  
J Gangadhar ◽  
M Jayajeevitha ◽  
Vanitha Prakash K

Reverse phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of pitavastatin in tablet dosage form. A Phenomenex Luna C18, 150×4.6 mm i.d, 5 µm particle size with mobile phase consisting of buffer 0.01M potassium dihydrogen ortho phosphate pH (3.75) adjusted with dilute orthophosphoric and acetonitrile in the ratio of 20:80 v/v was used. The flow rate was 1.2 mL/min and eluents were monitored at 248 nm. The retention time was 4.1min. The detector response was linear in the concentration of 25-150 µg/mL, with the regression coefficient of 0.9998. Quantification was done by calculating area of the peak and the limit of detection and limit of quantification were 1.9 µg/mL and 5.7 µg/mL respectively. The percentage assay of pitavastatin was 101.1%. The results of study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate which is useful for the routine determination of pitavastatin in bulk drug and in its pharmaceutical dosage forms.


INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (4) ◽  
pp. 78-81
Author(s):  
Rajesh Sharma ◽  
◽  
Mukesh C. Sharma ◽  
Gaurav Vijaywargiya

A simple, specific, accurate reversed phase high performance liquid chromatographic method was developed for the simultaneous estimation of clidinium bromide, chlordiazepoxide and dicyclomine hydrochloride. Chromatographic separation of the three drugs was performed on a Chromatopak C-18 column (25 cm x 4.6 i.d. x 5µm) as the stationary phase with a mobile phase composed of 0.1 % triethylamine in water pH adjusted by 5 % o-phosphoric acid and acetonitrile in the ratio 30:70 at a flow rate of 0.8mL/min, Detection was carried out at 210 nm. The retention times of clidinium bromide, chlordiazepoxide and, dicyclomine hydrochloride were found to be 3.9 min, 5.4 min, and 6.8 min, respectively. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ.


INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (01) ◽  
pp. 20-25
Author(s):  
S. M Samyuktha ◽  
◽  
P. G Prasanthi ◽  
K Mahesh ◽  
B. N Nalluri ◽  
...  

A simple, selective, accurate High Performance Liquid Chromatographic (HPLC) method was developed and validated for the analysis of Fenspiride hydrochloride in bulk and tablet dosage forms. Chromatographic separation was achieved isocratically using a C18 reverse phase column [Inertsil C18 column (250×4.6mm, 5μm)] utilizing a mobile phase containing 10mM Ammonium acetate: Acetonitrile (50:50 v/v) at a flow rate of 1 mL/min. The eluents were monitored at wavelength of 210 nm for a run time of 7 minutes at ambient temperature. The average retention time of the drug was found to be 4.6 minutes. The developed method was validated as per ICH guidelines to ascertain the reproducibility of the method. The method was found to be linear in the concentration range of 10-50 μg/mL with a good correlation coefficient of 0.998. The limit of detection (LOD) and limit of quantification (LOQ) were 0.007 and 0.021 μg/mL and the percentage recovery and assay were found to be 99.315 and 98.97%. Specificity with placebo by 3 D plots showed that the method was specific and free from interfering substances. Therefore, the fully validated method was good enough to carry out routine analysis of Fenspiride in bulk and tablet formulations.


2018 ◽  
Vol 10 (1) ◽  
pp. 124
Author(s):  
Podili Bhavani ◽  
Seelam Mohan ◽  
Kammela Prasada Rao

Objective: The present work describes the development and subsequent validation of a simple, precise and stability–indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of diethylcarbamazine citrate, guaiphenesin and chlorpheniramine maleate in tablet dosage forms.Methods: A simple, accurate, precise and robust RP-HPLC method was developed and validated for the estimation of diethylcarbamazine citrate, guaiphenesin and chlorpheniramine maleate. The chromatographic separation of all the three active components was achieved by using luna phenyl-hexyl column (250 mmx4.6 mm, dp=5 µm) with a mobile phase consisting of isocratic method with 0.1% triethylamine as buffer along with orthophosphoric acid adjusted to PH 2.5: acetonitrile (50:50v/v) at a flow rate 1.0 ml/min and ultraviolet detection at 210 nm.Results: The retention time of chlorpheniramine maleate, guaiphenesin and diethylcarbamazine citrate were 2.86, 4.89 and 7.76 min respectively. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. The established method was linear in the range of 1-15, 0.6-9, 0.02-0.3 µg/ml and correlation coefficient was 0.999, 0.9991, and 0.993 for diethylcarbamazine citrate, guaiphenesin and chlorpheniramine maleate respectively.Conclusion: The proposed method can be used for the quantitative analysis of diethylcarbamazine citrate, guaiphenesin and chlorpheniramine maleate.


2010 ◽  
Vol 7 (s1) ◽  
pp. S203-S208
Author(s):  
D. Anantha Kumar ◽  
CH. Venkata Kumar ◽  
P. Seetharamaiah ◽  
J. V. L. N. Seshagiri Rao

A rapid and reproducible reverse phase high performance liquid chromatographic method has been developed for the estimation of lamotrigine in its pure form as well as in pharmaceutical dosage forms. Chromatography was carried out on a Luna C18column using a mixture of potassium dihydrogen phosphate buffer (pH 7.3) and methanol in a ratio of 60:40 v/v as the mobile phase at a flow rate of 1.0 mL/min. The detection was done at 305 nm. The retention time of the drug was 6.1 min. The method produced linear responses in the concentration range of 10 to 70 μg/mL of lamotrigine. The method was found to be reproducible for analysis of the drug in tablet dosage forms.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (02) ◽  
pp. 39-46
Author(s):  
Babu D. China ◽  
◽  
C. Madhusudhana Chetty ◽  
Sk. Mastanamma

A simple, accurate, precise and robust reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Ertugliflozin (ETZ) and metformin (MFN) in bulk and in tablet dosage form. The method was carried out by used Waters (5μm, C18 250 x 4.6 mm) column with mobile phase consists of 0.75 mM sodium dihydrogen orthophosphate buffer pH adjusted to 8.5, with NaOH, and acetonitrile in the ratio of 60:40 v/v, a flow rate of 1.5 mL/min and photodiode detection at 263 nm. The method was validated as per ICH guidelines with different parameters, the mean retention times of ertugliflozin and metformin were found to be 3.5& 2.0 min, respectively. The correlation coefficient values of calibration curves were found to be 0.999 for both ETZ and MFN, respectively. The LOD and LOQ for ertugliflozin and metformin were found to be 0.02-0.06 μg/mL and 17.5-58.3 μg/mL respectively.


2010 ◽  
Vol 60 (2) ◽  
pp. 197-205 ◽  
Author(s):  
Dipti Patel ◽  
Natubhai Patel

Validated RP-HPLC and TLC methods for simultaneous estimation of tamsulosin hydrochloride and finasteride in combined dosage formsReversed-phase high-performance liquid chromatography (RP-HPLC) and thin-layer chromatography (TLC) methods have been developed and validated for simultaneous estimation of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a Phenomenex C18column using methanol/0.02 mol L-1ammonium acetate buffer/triethylamine (79.9 + 20 + 0.1,V/V/V) (pH 9.2) as mobile phase. TLC separation was achieved on an aluminium-backed layer of silica gel 60 F254using toluene/methanol/triethylamine (9 + 1.5 + 1,V/V/V) as eluent. Quantification was achieved with photodiode array (PDA) detection at 235 nm over the concentration range 0.5-16 and 1-50 μg mL-1with mean recovery of 99.8 ± 0.9 and 100.0 ± 0.8% for tamsulosin hydrochloride and finasteride, respectively, by the RP-HPLC method. Quantification was achieved with UV detection at 270 nm over the concentration range 100-2000 ng per spot and 250-5000 ng per spot with mean recovery of 98.9 ± 0.9 and 99.6 ± 0.7 % for tamsulosin hydrochloride and finasteride, respectively, by the TLC method. Both methods are simple, precise, accurate and sensitive and are applicable to the simultaneous determination of tamsulosin hydrochloride and finasteride in bulk drug and in combined dosage forms.


1970 ◽  
Vol 9 (2) ◽  
pp. 131-138 ◽  
Author(s):  
Md Ahsanul Haque ◽  
Asma Naznin ◽  
ANM Hamidul Kabir ◽  
Md Khalid Hossain ◽  
SM Ashraful Islam

A simple, selective and rapid reversed phase high performance liquid chromatographic (RPHPLC) method for the analysis of atenolol and amlodipine in tablet has been developed and validated. The chromatographic system consisted of a LC-20 AT pump, SPD-20 A UV/visible detector. The separation was achieved from C18 column at ambient temperature with a mobile phase consisting of methanol-acetonitrile buffer (solution of ammonium acetate and sodium pentanesulphonate ratio, 55:10:35 v/v, PH=3.00 adjusted with phosphoric acid) at a flow rate of 1ml/min and the retention time was about 1.67 minutes for atenolol and 5.0 minutes for amlodipine. The method is selective and able to resolve drug peaks from formulation excipients. The peaks of atenolol and amlodipine were well separated (resolution 11.65). The calibration curves were linear over the concentration range of 80% to 120% (r2 = 0.999 for both the drugs). The proposed method is accurate with 100.72% recovery for atenolol and 99.44% recovery for amlodipine and precise (%RSD of intra day variation were 0.53-0.152 for atenolol and 0.067-1.518 for amlodipine and %RSD of inter day variation were 0.024-1.518 for atenolol and 0.034-1.518 for amlodipine). The method has been used to test market products (six brands) and potency was found within limit (99.02%- 100.02% for atenolol and 97.4%-100.4% for amlodipine). Therefore, this method can be used as a more convenient and efficient option for the analysis of atenolol and amlodipine in tablet dosage form. Key words: Atenolol; amlodipine; method validation; HPLC; quantitative analysis DOI: http://dx.doi.org/10.3329/dujps.v9i2.7898 Dhaka Univ. J. Pharm. Sci. 9(2): 131-138, 2010 (December)


2007 ◽  
Vol 4 (1) ◽  
pp. 109-116 ◽  
Author(s):  
K. Basavaiah ◽  
B. C. Somashekar

A rapid, highly sensitive high performance liquid chromatographic method has been developed for the determination of finasteride(FNS) in bulk drug and in tablets. FNS was eluted from a ODS C18reversed phase column at laboratory temperature (30 ± 2°C) with a mobile phase consisting of methanol and water (80+20) at a flow rate of 1 mL min-1with UV detection at 225 nm. The retention time was ∼ 6.1 min and each analysis took not more than 10 min. Quantitation was achieved by measurement of peak area without using any internal standard. Calibration graph was linear from 2.0 to 30 μg mL-1with limits of detection (LOD) and quantification (LOQ) being 0.2 and 0.6 μg mL-1, respectively. The method was validated according to the current ICH guidelines. Within-day co efficients of variation (CV) ranged from 0.31 to 0.69% and between-day CV were in the range 1.2-3.2%. Recovery of FNS from the pharmaceutical dosage forms ranged from 97.89 – 102.9 with CV of 1.41-4.13%. The developed method was compared with the official method for FNS determination in its tablet forms.


INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (03) ◽  
pp. 39-45
Author(s):  
A Sherje ◽  
A. Sonalkar ◽  

A reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of olmesartan medoxomil (OLME) and chlorthalidone (CHLOR) in tablet dosage form. The analysis was performed on Inertsil ODS C18 (250 x 4.6 mm, 5 μ) using KH2PO4 phosphate buffer (pH) and acetonitrile as mobile phase in the proportion of 60: 40 v/v at flow rate of 1.0 mL/min. Detection of drugs was carried out in isocratic mode using UV detector at 275 nm. The retention time of OLME and CHLOR was 13.9 ± 0.1 min. and 4.4 ± 0.5 min., respectively and the total run time was 20 min. The method was validated according to the requirements of the United States Pharmacopeia. The percentage recoveries was found to be in the range of 98.9 - 100.7%. The method was successfully applied to the assay of OLME and CHLOR in tablet dosage form.


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