scholarly journals A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Fenofibrate in Bulk Drug and Tablet Dosage Formulation

2021 ◽  
pp. 306-312
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde ◽  
Ishwar Kakde
Keyword(s):  
Solvent System ◽  
Reversed Phase ◽  
Pharmaceutical Sciences ◽  
Reversed Phase Hplc ◽  
System Suitability ◽  
Water Ph ◽  
Hplc Technique ◽  
Bulk Drug ◽  
Tablet Dosage ◽  
Dosage Formulation

Aims: A accurate, precise, and stability-indicating Reversed-Phase HPLC technique has been established for the estimation of fenofibrate in tablet formulation. Study Design:  Experimental study. Place and Duration of Study: Department of Pharmaceutical Sciences, RTM Nagpur University, Nagpur-440033, Maharashtra, India between June 2019 and March 2020. Methodology: The chromatographic separation was attained on RP Princeton column (C18) (250 mm x 4.6 mm, 5 µ) with mobile solvent system as a mixture of water (pH 3.0 along o-phosphoric acid) and acetonitrile in the proportion (40:60) v/v, flow rate 1.0 ml per minute, at 240 nm. The retention time of fenofibrate was 3.905 minutes. Results: The method demonstrated linearity in the concentration range of 87-232 µg/ml with a coefficient of correlation (r2) of 0.9994. The % RSD was ˂2% and percentage recovery was found to be 99.13-100.74%. The assay of marketed tablet formulations was found to be 99.98%. Conclusion: The developed and validated technique as per ICH rules for specificity, accuracy, precision, linearity, and system suitability. Reverse Phase-HPLC technique was utilized to the market formulation.

scholarly journals A Validated Reversed-Phase HPLC Analytical Method for the Analysis of Rosuvastatin Calcium in Bulk Drug and Tablet Dosage Formulation

2021 ◽  
pp. 164-171
Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde
Keyword(s):  
Research Work ◽  
Solvent System ◽  
Reversed Phase ◽  
Reversed Phase Hplc ◽  
Analytical Technique ◽  
Chromatographic Condition ◽  
Bulk Drug ◽  
Tablet Dosage ◽  
Rosuvastatin Calcium ◽  
Dosage Formulation

Aims: The current research work has desired the validated reversed-phase analytical technique for the assurance of rosuvastatin calcium in bulk and tablet formulation. Study design: Experimental research work. Place and duration of study: UDPS, RTM Nagpur University, Nagpur, Maharashtra State, India between June 2019 and March 2020. Methodology: The segregation was obtained on a reversed-phase Princeton (C18) column with dimensions (250mm × 4.6mm, 5μ). The solvent system employed was a mixture of buffer, and methanol in the proportion (20:80) v/v, flow rate one ml per minute. Detection wavelength at 240 nm. The retention time (RT)beneath the developed chromatographic condition was found to be 2.848 minutes for rosuvastatin calcium. Results: The technique indicates linearity within the range of 2-16 µg per ml with a correlation coefficient (r2) is 0.9999. The analysis of marketed tablet formulations was erect to be 99.98%. The percentage RSD was ˂2% and % recovery was found to be 97.94-100.37%. Conclusion: The advanced reversed-phase HPLC technique was erect to be simple, specific, linear, sensitive, rapid, accurate, precise, economical, and can be utilized for daily quality control of rosuvastatin calcium in tablet and bulk formulations.

Validated reversed phase HPLC method for determination of pioglitazone hydrochloride in bulk drug and tablet formulations

2015 ◽  
Vol 70 (6) ◽  
pp. 744-746 ◽  
Author(s):  
Prem Sunder Prasad ◽  
Syed Sarim Imam ◽  
Mohammed Aqil ◽  
Mohammad Rizwan ◽  
Yasmin Sultana ◽  
...  
Keyword(s):  
Reversed Phase ◽  
Hplc Method ◽  
Reversed Phase Hplc ◽  
Tablet Formulations ◽  
Bulk Drug

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE AND DICYCLOMINE HYDROCHLORIDE IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (4) ◽  
pp. 78-81
Author(s):  
Rajesh Sharma ◽  
◽  
Mukesh C. Sharma ◽  
Gaurav Vijaywargiya
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Water Ph ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic ◽  
Clidinium Bromide

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.

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
Keyword(s):  
High Performance ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Dosage Forms ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Chlorpheniramine Maleate ◽  
Pharmaceutical Dosage Forms ◽  
Bulk Drug ◽  
Tablet Dosage

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.

scholarly journals A Reversed-Phase HPLC Method for Determination of Osteopontin in Infant Formula

2019 ◽  
Vol 9 (18) ◽  
pp. 3711 ◽  
Author(s):  
Md Abdul Wazed ◽  
Mohammed Farid
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Hplc Method ◽  
Milk Formula ◽  
Reversed Phase Hplc ◽  
Column Temperature ◽  
System Suitability ◽  
Relative Standard ◽  
Limit Of Quantitation

Osteopontin (OPN) is a multifunctional whey protein which has recently received much attention for possibly applications in fortifying infant milk formula (IMF) with its bioactivity. However, to date, there is no established high-performance liquid chromatography (HPLC) method to quantify this protein in milk or IMF. In this study, a rapid, simple, isocratic and reliable reversed-phase HPLC method was developed and validated to quantify the OPN in IMF. A C18 column (4.6 × 150 mm × 5 micron) was employed with 20% of 0.1% trifluoroacetic acid (TFA) and 80% of 60% acetonitrile in 0.1% TFA for 10 min detected at 214 nm. The flow rate was 0.3 mL/min with an injection volume of 10 µL. The column temperature was 40 °C, and the peak appeared after 4 min. The validation was based on the system suitability, linearity (r2 = 0.999), limit of detection (LOD) (0.14 mg/L), limit of quantitation (LOQ) (0.41 mg/L), precision (% relative standard deviation (RSD) < 0.2), recovery (% RSD < 3) and robustness. The results confirm that the method developed is suitable for OPN determination in IMF.

scholarly journals Validated HPTLC Method for Simultaneous Estimation of Atenolol and Aspirin in Bulk Drug and Formulation

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Vidhya K. Bhusari ◽  
Sunil R. Dhaneshwar
Keyword(s):  
Acetic Acid ◽  
Chromatographic Separation ◽  
Solvent System ◽  
Dosage Forms ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Aluminum Plates ◽  
Tablet Dosage ◽  
Hptlc Method

This paper describes a new, simple, precise, and accurate HPTLC method for simultaneous estimation of Atenolol and Aspirin as the bulk drug and in tablet dosage forms. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of n-butanol : water : acetic acid (8 : 2 : 0.2 v/v/v). Densitometric evaluation of the separated zones was performed at 235 nm. The two drugs were satisfactorily resolved with values and for Atenolol and Aspirin, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (100–600 ng/spot for Atenolol and Aspirin), precision (intraday % RSD was 0.48–1.03 and interday % RSD was 0.68–1.14 for Atenolol, and intraday % RSD was 0.61–1.03 and interday % RSD was 0.69–1.04 for Aspirin), accuracy ( for Atenolol and for Aspirin), and specificity in accordance with ICH guidelines.

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