STABILITY-INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE AND AZILSARTAN MEDOXOMIL IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (06) ◽  
pp. 51-61
Author(s):  
J. G Modi ◽  
◽  
J. K. Patel
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Good Resolution ◽  
Amlodipine Besylate ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Azilsartan Medoxomil

A novel, simple, rapid, and highly selective stability indicating RP-HPLC method was developed and validated for simultaneous estimation of azilsartan medoxomil (AZL) and amlodipine besylate HCl (AMLO) in tablet dosage form having strength of 20 mg and 2.5 mg, respectively. The effective chromatographic separation was achieved on a Phenomenex luna ODS C18 (15 cm X 4.6 mm internal diameter, 3.5 μm Particle size) with a mobile phase composed of phosphate buffer (pH-2.5) adjusted with ortho phosphoric acid : acetonitrile in the ratio of 60:40 v/v. The mobile phase was pumped using an isocratic HPLC system at a flow rate of 0.7 mL/min with injection volume 20μl and quantification of the analytes was done at detection wavelength 254 nm. The retention times were found to be 5.918 min and 14.901 min for AMLO and AZL, respectively. The proposed HPLC method was validated with respect to linearity, ranges, precision, accuracy, specificity, robustness, LOD, and LOQ as per ICH Q2 (R1) guideline. Calibration plots were linear over the concentration range of 75-125 µg/mL and 600-1000 µg/mL with correlation coefficients 0.9966 and 0.9948 for AMLO and AZL, respectively. Forced degradation studies were performed using hydrolysis, oxidation, photolytic, and thermal degradation conditions with good resolution between the degradants and analytes. Degradation products resulting from the stress studies did not interfere with the detection of AMLO and AZL, thus the proposed method is sensitive and stability-indicating. The validated HPLC method was successfully applied to the analysis of AMLO and AZL in tablet dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE IN BULK AND TABLET DOSAGE FORM

2018 ◽  
Vol 10 (6) ◽  
pp. 21
Author(s):  
S. S. Aher ◽  
R. B. Saudagar ◽  
Hemant Kothari
Keyword(s):  
Dosage Form ◽  
Accurate Method ◽  
Hplc Method ◽  
Plate Count ◽  
Simultaneous Estimation ◽  
Good Resolution ◽  
Rp Hplc ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Azilsartan Medoxomil

Objective: A simple, precise, accurate method was developed for the simultaneous estimation of azilsartan and chlorthalidone in bulk and tablet dosage form by RP-HPLC technique.Methods: Acetonitrile and water in the ratio of (70:30) pH 2.8 used as mobile phase run through (Cosmosil C18 (4.6ID x 250 mm, Particle size: 5 micron) column with a flow rate of 0.9 ml/min. The temperature of the column oven was maintained at 30 °C. Wavelength was selected 244 nm. Stock and working solutions were prepared by using the diluents water and acetonitrile in the ratio of 50:50. Runtime was fixed to 9 min.Results: Chlorthalidone and azilsartan were eluted at 2.02 and 3.92 with good resolution the plate count, tailing factor and all system suitability parameters are within ICH range. Azilsartan Medoxomil and Chlorthalidone were found to be linear low in concentration range of 80-400μg/ ml and 25-125μg/ ml respectively in the linearity study, regression equation and coefficient of correlation for Azilsartan Medoxomil and Chlorthalidone were found to be (y = 28695x+15397 r²=0.995) and (y=13444+27405 r² = 0.996) Percentage recovery for both Azilsartan Medoxomil and Chlorthalidone was found in range of 99.89%-99.96% indicating accuracy of the proposed work. Assay of the tablet was performed and found as 100.15%.Conclusion: All the parameters were within the ICH guidelines, and the method was economical and simple as retention times were less than in literature and decreased run time.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LINAGLIPTIN AND EMPAGLIFLOZIN

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (05) ◽  
pp. 68-71
Author(s):  
A Lakshmana Rao ◽  
◽  
T. Prasanthi ◽  
E. L Anusha
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, accurate and precise RP-HPLC method was developed for the simultaneous estimation of the linagliptin and empagliflozin in tablet dosage form. Chromatogram was run through Kromasil 250 x 4.6 mM, 5mM column, mobile phase containing 0.1% o-phosphoric acid buffer and acetonitrile in the ratio of 60:40%v/v was pumped through column at a flow rate of 1 mL/min. The optimized wavelength was 230 nm. Retention times of linagliptin and empagliflozin were found to be 2.759 min and 2.139 min. %RSD of the Linagliptin and Empagliflozin were found to be 0.5 and 0.6 respectively. Percentage assay was obtained as 99.91% and 100.15% for linagliptin and empagliflozin, respectively. LOD, LOQ values obtained for linagliptin and empagliflozin were 0.23 μg/ml and 0.44 μg/mL and 0.70 μg/mL and 1.34 μg/mL, respectively. Thus, the current study showed that the developed RP-HPLC method is sensitive and selective for the estimation of linagliptin and empagliflozin in combined dosage form.

scholarly journals Analytical method validation for estimation of avanafil and dapoxetine hydrochloride tablet dosage form by HPTLC method

2017 ◽  
Vol 4 (3) ◽  
pp. 171 ◽  
Author(s):  
Dhwani A. Shah ◽  
Kunjal L. Vegad ◽  
Ekta D. Patel ◽  
Hitesh K. Prajapati ◽  
Ronak N. Patel ◽  
...  
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Analytical Method Validation ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Chloroform Methanol ◽  
Hptlc Method ◽  
Dapoxetine Hydrochloride

Objective: A simple, specific, accurate and precise RP-HPTLC method has been developed and validated for simultaneous estimation of Avanafil and Dapoxetine.Methods: The chromatographic separation was achieved on Aluminium plates precoated with Silica gel 60 F254 using chloroform: methanol: ethyl acetate: glacial acetic acid (5:2:3:0.2, v/v/v/v) as mobile phase detected at 279 nm.Results: The correlation coefficient for RP-HPLC method was found to be 0.9987 for Avanafil and 0.9991 Dapoxetine and the linearity range was found to be 1040-3640 ng*spot-1 for Avanafil and 80-280 ng*spot-1 for Dapoxetine.Conclusions: The developed method was successfully applied to marketed tablet dosage form and the results were found with higher confidence.

scholarly journals Development and Validation of RP-HPLC Method for the estimation of Sofosbuvir and Ledipasvir in combined dosage form

2021 ◽  
Vol 12 (1) ◽  
pp. 523-529
Author(s):  
Naik Desai Prabhat Prabhaker ◽  
Kapupara Pankaj
Keyword(s):  
Hepatitis C ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Forms ◽  
Direct Acting Antiviral ◽  
Rp Hplc ◽  
Direct Acting ◽  
Tablet Dosage

Nowadays scientists aim at developing generic and specific methods for drugs in combined pharmaceutical dosage forms. The main aim was to develop and carry out validation using precision and accuracy for Sofosbuvir and Ledipasvir by applying RP-HPLC method. The dosage form in fixed combination of Sofosbuvir-Ledipasvir helps in effective treatment of genotypes of chronic hepatitis C virus. This combination of Sofosbuvir-Ledipasvir was the first FDA approved direct acting antiviral to treat hepatitis C. Both the drugs were optimized using mobile phase as acetonitrile: 0.1% orthophosphoric acid (55:50v/v) with pH 3.0. The mobile phase was optimized at maximum wavelength of 283nm. The separation was achieved using C18 Cosmosil (4.6 x 250mm) column with a particle size of 5µ. The method was specific eluting retention times of 3.7 for Sofosbuvir and 6.0 for Ledipasvir. Intra and interday precision was carried and %RSD was found to be less than 2%. The results were found to be accurate with percentage recovery of 99.76% and 99.10% for Sofosbuvir and Ledipasvir respectively. Linearity was carried out in the concentration ranging from 40-200µg/mL and 9-45µg/mL for Sofosbuvir and Ledipasvir respectively. Both the drugs showed the regression coefficient of 0.999. Deliberate changes in flow rate, pH and wavelength were made and found that method was robust. The developed method was found to be accurate, simple, specific, robust and precise for the simultaneous estimation of Sofosbuvir and Ledipasvir in tablet dosage form. 

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