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

Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde

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.

Author(s):  
Awdhut Pimpale ◽  
Rajendra Kakde ◽  
Ishwar Kakde

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.


2015 ◽  
Vol 70 (6) ◽  
pp. 744-746 ◽  
Author(s):  
Prem Sunder Prasad ◽  
Syed Sarim Imam ◽  
Mohammed Aqil ◽  
Mohammad Rizwan ◽  
Yasmin Sultana ◽  
...  

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.


2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Vidhya K. Bhusari ◽  
Sunil R. Dhaneshwar

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.


Molecules ◽  
2021 ◽  
Vol 26 (3) ◽  
pp. 732
Author(s):  
Mohammed H. Alqarni ◽  
Prawez Alam ◽  
Ahmed I. Foudah ◽  
Magdy M. Muharram ◽  
Faiyaz Shakeel

Due to unavailability of sustainable analytical techniques for the quantitation of piperine (PPN) in food and pharmaceutical samples, there was a need to develop a rapid and sensitive sustainable analytical technique for the quantitation of PPN. Therefore, the current research presents a fast and highly sensitive normal/reversed-phase high-performance thin-layer chromatography (HPTLC) technique with classical univariate calibration for the quantitation of PPN in various food spices of black pepper with traditional (TE) and ultrasound-assisted extracts (UBE) of various food spices of Piper nigrum L. under green analytical chemistry viewpoint. The amount of PPN in TE of four different spices of black pepper—namely BPMH, BPLU, BPSH, and BPPA—was found to be 309.53, 304.97, 282.82, and 232.73 mg g−1, respectively using a sustainable normal-phase HPTLC technique. However, the amount of PPN in UBE of BPMH, BPLU, BPSH, and BPPA was recorded as 318.52, 314.60, 292.41, and 241.82 mg g−1, respectively using a sustainable normal phase HPTLC technique. The greenness of normal/reversed-phase HPTLC technique was predicted using AGREE metric approach. The eco-scale was found to be 0.90, suggested excellent greenness of normal/reversed-phase technique. UBE of PPN was also found to be superior over TE of PPN. Overall, the results of this research suggested that the proposed normal/reversed-phase densitometry technique could be effectively used for the quantitation of PPN in food and pharmaceutical samples.


1999 ◽  
Vol 23 (1) ◽  
pp. 60-61
Author(s):  
O. I. Kalchenko ◽  
A. V. Solovyov ◽  
J. Lipkowski ◽  
V. I. Kalchenko

Stability constants of the host–guest complexes of 5,17-bis( N-tolyliminomethyl)-25,27-dipropoxycalix[4]arene with benzene derivatives were determined by reversed-phase HPLC in acetonitrile–water solution.


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