scholarly journals Novel Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) Method Development and Validation of Atorvastatin and Fenofibrate in Tablets

2020 ◽  
Vol 11 (02) ◽  
pp. 232-236
Author(s):  
Chandrasekhar Kudupudi ◽  
Manikandan Ayyar
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Related Compound ◽  
High Performance ◽  
Gradient Elution ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Compound A ◽  
Atorvastatin Calcium ◽  
Rp Hplc

A novel, simple, selective, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) gradient method was developed for the simultaneous estimation of atorvastatin and fenofibrate in the combined formulation. The drugs atorvastatin calcium and fenofibrate were separated in the presence of their impurities atorvastatin related compound H, fenofibrate related compound A, and fenofibrate related compound B. The drugs and related compounds were separated on Kromasil C18 (250 x 4.6, 5μ) with reverse-phase gradient elution. Water adjusted pH 4.0 with phosphoric acid used as a buffer in pump A and acetonitrile used as a solvent in pump B as a mobile phase with gradient elution. The flow rate was 2.0 mL/min. 254 nm was the detection wavelength. The retention times were about 4.6 minutes for fenofibrate related compound A, 5.2 minutes for atorvastatin calcium, 5.7 minutes for fenofibrate related compound B, 8.7 minutes for atorvastatin related compound H, and 17.6 minutes for fenofibrate. The linearity ranges for atorvastatin calcium and fenofibrate were 5.00 to 15.00 and 80 to 240 mcg/mL, respectively, with correlation coefficient 0.999 for both. The proposed method validated statistically with respect to system suitability, specificity, linearity, precision, accuracy, range, robustness, and ruggedness. The method was accurate, linear, precise, specific, selective, and rapid suitable for the quantitative estimation of atorvastatin and fenofibrate in tablets.

scholarly journals Novel Isocratic RP-HPLC Method Development and Validation of Rosuvastatin and Fenofibrate in Tablets

2020 ◽  
Vol 11 (03) ◽  
pp. 343-349
Author(s):  
Chandrasekhar Kudupudi ◽  
Manikandan Ayyar
Keyword(s):  
Related Compound ◽  
Method Development ◽  
Quantitative Estimation ◽  
Gradient Elution ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Phase Gradient ◽  
Compound A ◽  
Atorvastatin Calcium ◽  
Rp Hplc

A novel, simple, selective, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) gradient method was developed for the simultaneous estimation of atorvastatin and fenofibrate in the combined formulation. The drugs atorvastatin calcium and fenofibrate were separated in the presence of their impurities atorvastatin related compound H, fenofibrate related compound A, and fenofibrate related compound B. The drugs and related compounds were separated on Kromasil C18 (250 x 4.6, 5μ) with reverse-phase gradient elution. Water adjusted pH 4.0 with phosphoric acid used as a buffer in pump A and acetonitrile used as a solvent in pump B as a mobile phase with gradient elution. The flow rate was 2.0 mL/min. 254 nm was the detection wavelength. The retention times were about 4.6 minutes for fenofibrate related compound A, 5.2 minutes for atorvastatin calcium, 5.7 minutes for fenofibrate related compound B, 8.7 minutes for atorvastatin related compound H, and 17.6 minutes for fenofibrate. The linearity ranges for atorvastatin calcium and fenofibrate were 5.00 to 15.00 and 80 to 240 mcg/mL, respectively, with correlation coefficient 0.999 for both. The proposed method validated statistically with respect to system suitability, specificity, linearity, precision, accuracy, range, robustness, and ruggedness. The method was accurate, linear, precise, specific, selective, and rapid suitable for the quantitative estimation of atorvastatin and fenofibrate in tablets.

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 SIMULTANEOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF AMILORIDE HYDROCHLORIDE AND FUROSEMIDE IN A PHARMACEUTICAL DOSAGE FORM USING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD

2018 ◽  
Vol 11 (7) ◽  
pp. 215 ◽  
Author(s):  
Javed S Shaik ◽  
Nutan N Rao
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Uv Detector ◽  
Reverse Phase ◽  
Rp Hplc ◽  
The Stability ◽  
Amiloride Hydrochloride

Objective: The present study describes the stability indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of amiloride hydrochloride and furosemide in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu LC-2030 HPLC system equipped with UV detector, and chromatographic separation was carried on Shim-pack C18 (250 mm×4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the runtime was 4min. The mobile phase consisted of water and acetonitrile in the ratio of 35:65, and elements were scanned using a UV detector at 281 nm.Results: The retention time of amiloride hydrochloride and furosemide was found to be 1.92 min and 3.14min, respectively. Linearity was found to be 12–28 ppm for amiloride hydrochloride and 96–224 ppm for furosemide, respectively. Limit of detection and limit of quantification for amiloride hydrochloride were 0.381 ppm and 1.156 ppm and for furosemide were 2.00 ppm and 6.068 ppm, respectively.Conclusion: The stability indicating method was developed by subjecting the drugs to stress conditions such as acid and base hydrolysis, oxidation, humidity, photolytic, and thermal degradation, and the degraded products formed were resolved successfully from the samples.

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 RELATED SUBSTANCE METHOD DEVELOPMENT AND VALIDATION OF LOXAPINE SUCCINATE IN CAPSULE DOSAGE FORM BY REVERSE PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

2019 ◽  
pp. 203-207
Author(s):  
KHUSHBU A THAKOR ◽  
PASHA TY
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Related Compound ◽  
High Performance ◽  
Dosage Form ◽  
Stress Condition ◽  
Reverse Phase ◽  
Related Substance ◽  
Compound A ◽  
Acid And Base

Objective: The present study gives a simple, rapid, and accurate stability indicating reverse phase high-performance liquid chromatography method for the determination of loxapine succinate and its related substance (related compound A) in capsule dosage form. Methods: Loxapine succinate and its related substance were attained on a C18 Purospher star (250 mm × 4.6 mm, 5 μm particle size) column at 254 nm detection wavelength, 1.0 ml/min as a flow rate, and 10 μl injection volume. Water:methanol: Triethylamine: Tetrahydrofuran (50:40:1:10) was used a mobile phase, and column oven temperature was 30°C. Results: The resolution between loxapine succinate and known unknown impurities was >2.0. The correlation coefficient (0.999) value indicates the linear relationship between the concentration and peak areas. The accuracy study was performed by spiking method. Loxapine succinate was exposed to the stress condition of hydrolysis (acid and base), oxidative, thermal, and photolytic degradation. Loxapine succinate was found to degrade unquestionably in acid and base stress condition and almost stable in oxidative, thermal, and photolytic conditions. Conclusion: The degradant products were well resolved from leading peak and its related compound A peak and any other unknown peak justifying the stability indicating capability of the method. The developed method was validated as per the ICH guidelines. This method is used for periodic analysis in laboratory.

scholarly journals STABILITY INDICATING REVERSE-PHASE HIGH- PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF TELMISARTAN AND BENIDIPINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 (5) ◽  
pp. 342
Author(s):  
Majan Naim ◽  
Aejaz Ahmed ◽  
Khan Gj
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Development And Validation

 Objective: Development and validation of stability indicating reverse-phase high- performance liquid chromatography (RP-HPLC) method for simultaneous estimation of telmisartan (TEL) and benidipine hydrochloride (BND) in pharmaceutical dosage form.Methods: Reverse phase chromatography was selected because of its suggested use for ionic and moderate to non-polar compounds. Reverse phase chromatography is simple, suitable, better regarding efficiency, stability, and reproducibility. C18 column, a 250×4.6 mm column of 5.0 μm particle packing, was selected for separation of TEL and BND. Different solvent systems were tried and optimized in combinations as mobile phase. TEL (40 μg/ml) and BND (4 μg/ml) in buffer, pH 4.0: Methanol (50:50) was developed as it was showing good peak shapes and a significant amount of resolution. The mobile phase was flowed at 1.0 ml/min with detection of both the analytes at 210 nm using photodiode array detector.Result: Development of method was done, and validation was accomplished using specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantitation. The method was found linear from 20 to 60 μg/ml and 2–6 μg/ml for TEL and BND individually. The percentage recoveries of TEL 100.46% and BND100.08% were, respectively.Conclusion: This stability indicating RP-HPLC methods were developed by degradation of sample and compared with standard. The percentage relative standard deviation was also <2 % showing high degree of precision of the proposed method. The proposed method can be used for routine analysis of benidipine HCl and TEL in combined dosage form and quality control in bulk manufacturing.

scholarly journals DEVELOPMENT AND VALIDATION OF REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF OLANZAPINE AND ARIPIPRAZOLE IN SYNTHETIC MIXTURES

2020 ◽  
pp. 162-168
Author(s):  
MEGHA PATEL ◽  
PARESH PATEL ◽  
DHARA PATEL
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Control Analysis ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Rp Hplc ◽  
Liquid Chromatography Method

Objective: A simple, rapid, accurate, precise, specific, and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ) and aripiprazole (APR) in synthetic mixtures. Methods: The stationary phase used for chromatographic separation was Phenomenex C18 column (250 mm × 4.6 mm i.d, particle size 5 μm) and mobile phase used for separation was methanol: Phosphate buffer (pH 3) taken in ratio of 75:25 %v/v. The flow rate was used 1.0 ml/min at room temperature and drugs detected at 240 nm with injection volume 20 μL. Results: The retention time for OLZ and APR was found to be 4.231 and 6.523 min, respectively. The linearity was performed using a concentration range of 0.5–3.0 for both drugs. The correlation coefficient was found to be 0.999 for OLZ and APR. The % purity of both the drug was found to be 98–102%. The proposed RP-HPLC method has been validated, according to International council on harmonization Q2 (B) guidelines. Conclusion: There was no interference of any diluents and excipients in the determination of drugs from synthetic mixture. Hence, the developed method can be used for routine quality control analysis.

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