A stability indicating RP-HPLC- PDA method for simultaneous estimation of segesterone acetate and ethinyl estradiol in tablet dosage form

2021 ◽  
Vol 25 (9) ◽  
pp. 113-117
Author(s):  
Narendra Reddy Yeragodala ◽  
Sreeramulu Jadi
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Ethinyl Estradiol ◽  
Simultaneous Estimation ◽  
Precise Method ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage

A simple, accurate, precise method was developed for the simultaneous estimation of the Segesterone acetate and Ethinyl estradiol in a tablet dosage form. The chromatogram was run through Discovery C18 150 x 4.6mm, 5mm column and mobile phase containing buffer 0.01N KH2PO4: Acetonitrile taken in the ratio 50:50 was pumped through the column at a flow rate of 1 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 240.0 nm. Ethinyl estradiol and Segesterone acetate were eluted at 2.348 min and 3.855 min respectively.

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 New Analytical Method for The Simultaneous Estimation of Levodropropizine And Chlorpheniramine In Pharmaceutical Dosage Form

2021 ◽  
pp. 33-42
Author(s):  
Vepa Vishnu Vardhan Reddy ◽  
P.Sreenivasa Prasanna ◽  
K. Thejomoorthy
Keyword(s):  
Quality Control ◽  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate, precise method was developed for the simultaneous estimation of the Levodropropizine and Chlorpheniramine in Tablet dosage form. The chromatogram was run through Ascentis C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer Kh2po4: Acetonitrile was taken in the ratio 40:60was pumped through the column at a flow rate of 1.0ml/min. The buffer used in this method was Kh2po4. The temperature was maintained at 30°C. The optimized wavelength selected was260nm. The retention time of Levodropropizine and Chlorpheniramine was found to be 2.276min and 2.848. %RSD of the Levodropropizine and Chlorpheniramine was and found to be 0.7 and 0.7 respectively. %Recovery was obtained as 100.73% and 99.03% for Levodropropizine and Chlorpheniramine respectively. LOD, LOQ values obtained from regression equations of Levodropropizine and Chlorpheniramine were 0.14, 0.02, and 0.43, 0.06 respectively. Regression equation of Levodropropizine is y = 67089x + 5956.8 and y = 226526x + 13941 of Chlorpheniramine. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.  

scholarly journals Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form

2021 ◽  
pp. 49-57
Author(s):  
Pemra Raju ◽  
K. Thejomoorthy ◽  
P.Sreenivasa Prasanna
Keyword(s):  
Quality Control ◽  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Precise Method ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate, precise method was developed for the simultaneous estimation of the Darunavir and Ritonavir in Tablet dosage form. The chromatogram was run through Agilent C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% Formic acid: Acetonitrile, taken in the ratio 70:30 was pumped through the column at a flow rate of 0.95 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 293 nm. The retention times of Darunavir and Ritonavir were found to be 2.369min and 2.911. %RSD of the Darunavir and Ritonavir were and found to be 0.7 and 0.5 respectively. %Recovery was obtained as 99.67% and 99.78% for Darunavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Darunavir and Ritonavir were 1.49, 5.191and 0.37, 1.11 respectively. Regression equation of Darunavir is y = 5421x + 640.7, and y = 3870.x + 5191 of Ritonavir. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.

scholarly journals Stability-indicating RP-HPLC method development and validation for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Rameshwar Gholve ◽  
Sanjay Pekamwar ◽  
Sailesh Wadher ◽  
Tukaram Kalyankar
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Solution Stability ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Study Results ◽  
Tablet Dosage ◽  
Rosuvastatin Calcium

Abstract Background The stability-indicating chromatographic method was developed and validated for simultaneous estimation of telmisartan and rosuvastatin calcium in bulk and in tablet dosage form. The RP-HPLC elution was carried out at 242.0 nm using column Oyster ODS3 (150 × 4.6 mm, 5 µm) isocratically, and a mobile phase containing 10 mM phosphate buffer with 1.1 g octane-1-sulfonic acid sodium salt having pH 2.5 (adjusted with 5% OPA) and acetonitrile, with a proportion of 500:500, v/v was pumped through the column maintained at ambient (about 25 °C) temperature with 1.0 mL/min flow rate. The proposed method was validated according to ICH Q2 (R1) guideline. Results Telmisartan and rosuvastatin were eluted at 2.553 min and 4.505 min, respectively. The method is linear from 99.9073 to 299.7218 µg/mL for telmisartan (R2 = 1.000) and 23.6841 – 71.0522 µg/mL for rosuvastatin (R2 = 0.999). The average recovery percentage was found 100.51, 99.76, and 99.14% for telmisartan and 99.68, 99.72, and 98.56% for rosuvastatin at three different levels. Results of method repeatability and intermediate precision were found within acceptable limits. Results of solution stability showed that mobile phase was stable for 2 days; standard and sample preparations are stable for 1 day at room temperature as well as in the refrigerator (2–8 °C). Also, forced degradation study results show that method is stability indicating as capable of distinguishing the active analytes peak from the degraded product. Conclusion The developed stability-indicating method is linear in studied concentration range as well as precise, accurate, specific, and robust. Hence, successfully this method can be used for routine analysis and stability study. Graphical abstract

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 Development and Validation of RP-HPLC for Estimation of Neratinib in Bulk and Tablet Dosage Form

2019 ◽  
Vol 11 (02) ◽  
Author(s):  
M Lakshmi Kanth ◽  
B Raj Kama
Keyword(s):  
Flow Rate ◽  
Retention Time ◽  
Chromatographic Separation ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Rp Hplc ◽  
Monopotassium Phosphate ◽  
Development And Validation ◽  
Tablet Dosage

An accurate RP-HPLC method developed for the estimation of Neratinib in bulk and tablet dosage form. The method is and validated for parameters linearity, accuracy, suitability, specificity, precession, LOD, LOQ and robustness. An Altima column (150 mm × 4.6 mm × 5μ) used for chromatographic separation within a runtime of 6 min. The mobile phase buffer (monopotassium phosphate) and acetonitrile (60:40 v/v) with 0.1% formic acid is used. The flow rate maintained at 1.0 ml/min with the effluents monitored at 215 nm. The Neratinib analyzed at retention time of 4.001. The concentration linear over 30-180μg/ml with regression equation y = 6065.6x + 795.43 and regression co-efficient 0.999.

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