STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FIMASARTAN BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY IN BULK AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
pp. 138-146
Author(s):  
SRUTHI A ◽  
UTTAM PRASAD PANIGRAHY
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Internal Diameter ◽  
Uv Detector ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

Objective: A rapid, sensitive and specific reverse phase High performance liquid Chromatography (RP-HPLC) method was developed for the estimation of Fimasartan in bulk and pharmaceutical dosage form. Method: The RP-HPLC analysis was performed isocratically on a Primacel C18 column (150 mm × 4.6 mm internal diameter, 5 μm particle size) using mobile phase of composition Acetonitrile and 0.1% orthophosphoric Acid in 80:20, v/v proportions with a flow rate of 0.8 ml/min. Results: The analyte was monitered with UV-detector at 265 nm. In the developed method Fimasartan elutes at a typical retention time of 2.4 min. The proposed method is having linearity in the concentration ranging from 5-30 μg/ml of Fimasartan. Conclusion: : The method was statistically validated and had been applied to analysis of the drug in bulk and pharmaceutical dosage form.

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND ZIDOVUDINE IN TABLET BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2020 ◽  
pp. 73-77
Author(s):  
BHOOMI D PATEL ◽  
MEHTA BHAVYA ◽  
ANKIT B CHAUDHARY
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Rp Hplc

Objective: The objective of the study was to develop and validate reverse-phase high-performance liquid chromatography (RP-HPLC) method and apply method to tablet dosage form. Methods: A simple, rapid, economical, precise, and accurate RP-HPLC method for simultaneous estimation of lamivudine and zidovudine in their combined dosage form has been developed. Results: A RP-HPLC method was developed for the simultaneous estimation of lamivudine and zidovudine. In their combined dosage form has been developed. The separation was achieved by LC-C18 column (150 mm ×4.6 mm, 5 μm) and water: methanol (65:35v/v) as mobile phase, at a flow rate of 0.8 ml/min. Detection was carried out at 272 nm. Retention time of lamivudine and zidovudine was found to be 3.007 min and 4.647, respectively. The method has been validated for linearity, accuracy, and precision. The assay method was found to be linear from 50% to 150% for lamivudine and zidovudine. Conclusion: Developed method was found to be accurate, precise, and rapid for simultaneous estimation of lamivudine and zidovudine in their combined dosage form.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DILTIAZEM HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP- HPLC

2018 ◽  
Vol 2 (2) ◽  
pp. 78-84
Author(s):  
Bhagyashree R. Patil ◽  
O. G. Bhusnure ◽  
B. N. Paul ◽  
A. Y. Ghodke ◽  
Suraj S. Mulaje
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Diltiazem Hydrochloride ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Validation Parameters

A simple, specific, precise and accurate Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the estimation of Diltiazem Hydrochloride in bulk and pharmaceutical dosage form. The chromatographic determination was performed on isocratic high performance liquid chromatography system of Agilent model no.1220. The separation was conducted by using column of Zorbax [C8 (5µ, 4.6 mm×250)] with mobile phase consisting of buffer and Acetonitrile in the ratio of (60:40). The mobile phase was delivered at the flow rate of 1.0ml/min. The eluent was monitored at wavelength 240 nm and found a sharp and symmetrical peak with retention time of 4.66min. The method was validated for linearity, accuracy, precision, specificity, robustness. Recovery of Diltiazem Hydrochloride was found to be in the range of 98%-102%. The method was found to be linear over the concentration range 50-150 µg/ml with coefficient correlation r2 = 0.995. After developing method, validation parameters were carried out successfully and obtained results were complied with USP monograph.

scholarly journals DEVELOPMENT AND VALIDATION OF REVERSE PHASE-HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY TECHNIQUE FOR THE CONCOMITANT ASSESSMENT OF OMEPRAZOLE AND PIPERINE IN BULK FORM

2018 ◽  
Vol 11 ◽  
Author(s):  
Susithra E ◽  
Pavani Ch
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Correlation Coefficients ◽  
Literature Study ◽  
Uv Detector ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Relative Standard ◽  
Double Beam

Objective: The immense literature study was carried out and disclosed that here no method arrived for the concomitant assessment of omeprazole and piperine in bulk form by using RP-HPLC. Hence, an effort was assembled to arise a easy, specific, precise, reliable, linear, rapid, and validated reverse phase-high-performance liquid chromatography (RP-HPLC) technique for the simultaneous assessment of omeprazole and piperine in bulk form.Methods: The chromatographic analysis of omeprazole and piperine was performed using a RP-HPLC (WATERS) provided with autosampler and ultraviolet (UV) detector with the software of EMPOWER Version 2. The chosen conditions were isocratic separation with two mobile phase composed of acetonitrile:buffer (phosphate buffer: pH 6.5 ± 0.1) (55:45). Detection was carried out using UV/visible double-beam spectrophotometer at 320 nm. The method was validated as per the ICH guidelines.Results: The retention time for omeprazole and piperine by proposed HPLC method was found to be 2.767 and 4.029 min, respectively. The correlation coefficients are 0.999. The developed chromatographic method was found to be accurate with recovery 99.2–99.8% and was found within the acceptance criteria (i.e., 98.0–102.0%) with acceptable % relative standard deviation of not >2% at each level.Conclusion: Thus, the proposed HPLC procedure for the concomitant assessment of omeprazole and piperine was accurate, precise, linear, robust, simple, and economic. 

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NEW STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 241 ◽  
Author(s):  
Geetha Susmita A ◽  
Rajitha G ◽  
Ramya Yadav Y ◽  
Uma P
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Tablet Dosage

Objective: The objective of this study was to develop and validate a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of the metformin and empagliflozin in tablet dosage forms.Methods: The chromatographic conditions were optimized and it was run through Std. BDS (250 mm × 4.6 mm, 5 m) column with mobile phase consisting of 0.1% orthophosphoric acid buffer: acetonitrile in the ratio of 50:50. The flow rate was 1 ml/min and optimized wavelength was 210 nm. Temperature was maintained at 30°C.Results: The retention times of metformin and empagliflozin were found to be 2.588 min and 3.679 min and percentage relative standard deviation (RSD) of the metformin and empagliflozin was found to be 0.59 and 1.2, respectively. Percentage recovery was in the range of 100.01–100.65% for metformin and empagliflozin, respectively.Conclusion: A sensitive, rapid, and specific method has been developed for the simultaneous estimation of metformin and empagliflozin using RP-HPLC in tablet dosage form.

scholarly journals ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF NEW STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN TABLET DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 241
Author(s):  
Geetha Susmita A ◽  
Rajitha G ◽  
Ramya Yadav Y ◽  
Uma P
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard ◽  
Tablet Dosage

Objective: The objective of this study was to develop and validate a stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of the metformin and empagliflozin in tablet dosage forms.Methods: The chromatographic conditions were optimized and it was run through Std. BDS (250 mm × 4.6 mm, 5 m) column with mobile phase consisting of 0.1% orthophosphoric acid buffer: acetonitrile in the ratio of 50:50. The flow rate was 1 ml/min and optimized wavelength was 210 nm. Temperature was maintained at 30°C.Results: The retention times of metformin and empagliflozin were found to be 2.588 min and 3.679 min and percentage relative standard deviation (RSD) of the metformin and empagliflozin was found to be 0.59 and 1.2, respectively. Percentage recovery was in the range of 100.01–100.65% for metformin and empagliflozin, respectively.Conclusion: A sensitive, rapid, and specific method has been developed for the simultaneous estimation of metformin and empagliflozin using RP-HPLC in tablet dosage form.

scholarly journals REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE IN SOLID DOSAGE FORM

2019 ◽  
Vol 12 (1) ◽  
pp. 112
Author(s):  
Juluri Krishna Dutta Tejaswi ◽  
Govinda Rajan R
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Dosage Form ◽  
Forced Degradation ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Tenofovir Alafenamide

Objective: A stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of emtricitabine (EMT), rilpivirine (RIL), and tenofovir alafenamide (TAF) in combined dosage forms and its API.Methods: Chromatographic separation was achieved on Waters ACQUITY RP-HPLC with PDA detector having Zodiac C18 Column (250×4.6×5μ) using mobile phase mixture of phosphate buffer: acetonitrile in the ratio of 40:60 v/v at 262 nm.Results: The assay was performed with tablets, and the % assay was found to be 100.104 for EMT, 99.74 for RIL, and 102.41 for TAF which shows that the method is useful for routine analysis. The linearity was found to be linear with a correlation coefficient of 0.999, which shows that the method is capable of producing good sensitivity. The retention time (RT) of EMT, RIL, and TAF using optimum conditions was found to be 2.517, 3.273, and 6.697 min. Forced degradation studies (FDS) were performed on sample using acid, base, thermal, photolytic, and peroxide degradation.Conclusion: Due to its simplicity, rapidness, high precision, and low RT value, this method was successfully applied to the estimation of EMT, RIL, and TAF combined dosage form. The drugs were found to be stable at FDS, and the net degradation was found to be within the limits.

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