scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ROSUVASTATIN, CLOPIDOGREL IN BULK AND PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 10 (10) ◽  
pp. 50
Author(s):  
Pooja Pisal ◽  
Ganesh Nigade ◽  
Amol Kale ◽  
Smita Pawar
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Assay Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Relative Standard

Objective: To develop a novel, accurate, precise and linear reverse phase high-performance liquid chromatography (RP-HPLC) and Stability Indicating Assay Method (SIAMs) for simultaneous, qualitative and quantitative estimation of aspirin, rosuvastatin and clopidogrel in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines.Method: In the present work, good chromatographic separation was achieved by isocratic method using a BISCOF HPLC C18 column (250 mm ×4.6, 5 µm) and a mobile phase consisting of water at pH 2.51 with 0.1 % (v/v) orthophosphoric acid (OPA): acetonitrile in the ratio 50:50, at a flow rate of 1 ml/min. The effluents obtained were monitored at 237 nm with the UV-visible detector.Results: The retention time of aspirin, rosuvastatin, and clopidogrel was found to be 4.3 min, 7.6 min and 16.6 min respectively. For linearity seven-point calibration curves were obtained in a concentration range from 1-7 µg/ml for aspirin, rosuvastatin and clopidogrel with correlation coefficient 0.999, 0.9989, 0.9988 respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise. In the present study stability indicating an RP-HPLC method for the combination was tested by degrading the drugs together under various stress condition like acid, base and neutral hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH.Conclusion: The developed RP-HPLC method is simple, economic, specific, accurate and precise for the simultaneous estimation of aspirin, rosuvastatin, and clopidogrel in the combined capsule dosage form. The developed stability indicating analytical method can be used to check the stability of the compounds and was found suitable to determine % degradation of drugs in pharmaceutical dosage form.

scholarly journals Analytical Method Development and Validation for the Simultaneous Estimation of Aspirin, Clopidogrel and Rosuvastatin in Pharmaceutical Dosage Form

2019 ◽  
Vol 9 (4-s) ◽  
pp. 432-438
Author(s):  
Pradip Kumar Tiwari ◽  
Amit Jain ◽  
BK Dubey ◽  
GK Pandey ◽  
Suresh Dhakad
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Quantitative Estimation ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Relative Standard

A new, simple, novel, accurate, precise, reliable, rapid and linear reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and fully validated for simultaneous qualitative and quantitative estimation of   Rosuvastatin (ROS), Clopidogrel (CLOP) and Aspirin (ASP) in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines. In the present work, good chromatographic separation was achieved by isocratic method using a Hypersil BDS C18 column (250 mm ×4.6, 5 μm) and a mobile phase consisting of KH2Po4 buffer pH-6.0: acetonitrile in the ratio 60:40, at a flow rate of 1 ml/min. The effluents obtained were monitored at 242nm with the UV-visible detector. The calibration curves obtained were linear (r2=0.999) over the concentration range of 7.5-22.5μg/ml and 1-3μg/ml for CLOP, ASP and ROS respectively. A run time of 7.0 minutes for each sample made it possible to analyze more than 200 samples per day. The retention time of ASP, CLOP and ROS was found to be 3.103 min, 4,277 min and 5.707 min respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise  therefore the method can be used for routine monitoring of CLOP, ASP and ROS in industry in the assay of bulk drug and dosage form. Keywords: RP-HPLC, Rosuvastatin, Clopidogrel, Aspirin, Method validation, ICH guidelines.

scholarly journals DEVELOPMENT AND STABILITY INDICATING HPLC METHOD FOR DAPAGLIFLOZIN IN API AND PHARMACEUTICAL DOSAGE FORM

2017 ◽  
Vol 9 (5) ◽  
pp. 33 ◽  
Author(s):  
Mitali V. Verma ◽  
Chirag J. Patel ◽  
M. M. Patel
Keyword(s):  
Dosage Form ◽  
Hplc Method ◽  
Assay Method ◽  
Array Detector ◽  
Diode Array Detector ◽  
Hydrogen Phosphate ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Relative Standard ◽  
Potassium Hydrogen

Objective: To develop precise, accurate and reproducible stability assay method by RP-HPLC for estimation of dapagliflozin in API and pharmaceutical dosage form.Methods: The adequate separation was carried using agilent C18 (4.6 ml (millimeter)*150,5 µm (micromiter), mixture of acetonitrile: di-potassium hydrogen phosphate with pH-6.5 adjusted with OPA (40:60 %v/v) as a mobile phase with the flow rate of 1 ml/min (milliliter/minute) and the effluent was monitored at 222 nm (nanometer) using photo diode array detector. The retention time of dapagliflozin API and dapagliflozin tablet were 3.160 min (minute) and 3.067 min (minute) respectively.Results: Linearity for dapagliflozin was found in the range of 50-150µg/ml (microgram/milliliter) (R2 = 0.99) respectively. The accuracy of the present method was evaluated at 50 %, 100% and 150%. The % recoveries of dapagliflozin API and tablet were found to be in the range of 99.00–99.99 % and 98.50–99.99 % respectively. Precision studies were carried out and the relative standard deviation values were less than two. The method was found to be robust.Conclusion: The proposed method was found to be specific, accurate, precise and robust can be used for estimation of dapagliflozin in API and Pharmaceutical dosage form.

scholarly journals SIMPLE ANALYTICAL METHOD FOR THE SIMULTANEOUS ESTIMATION OF HYDROCHLOROTHIAZIDE AND CANDESARTAN BY RP-HPLC

2017 ◽  
Vol 9 (6) ◽  
pp. 34
Author(s):  
Madhavi K. ◽  
Navamani M. ◽  
Prasanthi C.
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
Quantitative Estimation ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Limit Of Quantitation ◽  
Pharmaceutical Industries

Objective: To develop a simple, rapid, economic, accurate and precise reverse phase-high performance liquid chromatographic (RP-HPLC) method for the determination of hydrochlorothiazide and candesartan in the pharmaceutical dosage form and to validate as per international conference on harmonization (ICH) guidelines.Methods: The chromatographic separation was performed on Silanol BDS C18 column (250 x 4.6 mm, 5 μm), a mobile phase consisting of water (pH adjusted to 2.8 with orthophosphoric acid): acetonitrile (30:70 % v/v), with a flow rate 1 ml/min and the detection wavelength of 210 nm using photodiode array (PDA) detector.Results: The developed method resulted in elution of hydrochlorothiazide at 2.28 min and candesartan at 4.28 min. The calibration curves were linear (r2=0.999) in the concentration range of 6.25-18.75 μg/ml and 8-24 μg/ml for hydrochlorothiazide and candesartan respectively. The percentage recoveries were found to be 99.78-100.39 for hydrochlorothiazide and 99.87-100.64 for candesartan. The limit of detection (LOD) was found to be 0.410 μg/ml and 0.699 μg/ml for hydrochlorothiazide and candesartan respectively. The limit of quantitation (LOQ) was found to be 1.367 μg/ml and 2.330 μg/ml for hydrochlorothiazide and candesartan respectively.Conclusion: A simple, economic, accurate, precise, linear and rapid RP-HPLC method was developed for simultaneous quantitative estimation of hydrochlorothiazide and candesartan in bulk and pharmaceutical formulation and the method was validated as per ICH guidelines. Hence, the method holds good for the routine analysis of hydrochlorothiazide and candesartan in various pharmaceutical industries as well as in academics.

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.

A Validated Stability Indicating RP-HPLC Method for the Estimation of an Anti-Cancer Drug Regorafenib in Pure and Pharmaceutical Dosage Form

2017 ◽  
Vol 4 (1) ◽  
pp. 5-10 ◽  
Author(s):  
Ramesh Jayaprakash ◽  
Senthil Kumar Natesan
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Cancer Drug ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, economic, accurate, sensitive, specific and precise stability indicating reverse phase high performance liquid chromatographic [RP-HPLC] method for the determination of Regorafenib in pure and tablet dosage from was developed and validated. The chromatographic separation was carried out using Phenomenex Luna-C18 column (4.5x250 mm; 5 µm particle size) as a stationary phase and methanol: acetonitrile: water (55:25:20 v/v/v) as a mobile phase. The flow rate of 1 mL/min was used with PDA detection at 275 nm. The retention time of Regorafenib was 2.480 min. RP-HPLC method was developed with linearity range of 40-240 µg/mL of Regorafenib. The correlation coefficient [r2] was found to be 0.9999. The assay results obtained was in good agreement with the corresponding labeled amount by developed method within range of 98.83 ± 0.6937. Accuracy of the method was confirmed by recovery studies and the recoveries were found to be between 99.61 % and 100.22 %, the corresponding %RSD was found to be 0.2029. Precision, LOD, LOQ, specificity, robustness and ruggedness were performed as per ICH Q2(R1) guidelines and were within the acceptance criteria. This method can be conveniently used to detect the possible degradation product in the dosage form of Regorafenib during stability studies (acidic, alkaline, oxidative, thermal and photolytic). The method proved to be effective on the analysis of stressed marketed tablet formulation.

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 of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Amlodipine and Olmesartan in Pure and Pharmaceutical Dosage Form

2018 ◽  
Vol 10 (05) ◽  
Author(s):  
Dhiraj Kumar ◽  
Susanta Kumar Panda ◽  
Sudhir Kumar Sahoo
Keyword(s):  
Dosage Form ◽  
Degradation Products ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Standard Curve ◽  
Stress Studies ◽  
Rp Hplc ◽  
Limit Of Quantitation

A precise, accurate, economical and simple stability indicating RP-HPLC method was developed for the estimation of Amlodipine (AML) and Olmesartan (OLM) in bulk and pharmaceutical dosage form. Method was performed on a octadecyl silane column with dimensions 4.6 x 250 mm having particle size 5 micron. The mobile phase used in the method is TEA Buffer (pH 3.0) and acetonitrile in proportion of 25:75 respectively. The flow rate was maintained at 1.0 ml/ min and effluent was monitored at 258 nm. The drug was subjected to acid and alkali hydrolysis, oxidation, photolysis and heat as stress conditions. The method was validated for specificity, linearity, precision, accuracy, robustness and system suitability. The retention times were observed at 2.39 min and 3.33 min for AML and OLM respectively. The standard curve was found linear over a range of 05–35 μg/ml for AML and OLM. Similarly an average correlation coefficient was also obtained at 0.999 for AML and OLM. The limit of quantitation (LOQ) of this method was 2μg/ml for Amlodipine and Olmesartan. The absolute recovery was 100% for Amlodipine and 100.3 for Olmesartan. Degradation products produced as a result of stress studies did not interfere with the detection of AML and OLM and the assay can thus be considered stability-indicating.

scholarly journals A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PYRANTEL PAMOATE AND PRAZIQUANTEL IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 62-67 ◽  
Author(s):  
Rajesh R. ◽  
JITHU JERIN JAMES
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Correlation Coefficients ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Pyrantel Pamoate ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Tablet Dosage

Objective: To develop a simple, accurate and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and subsequently validate for the simultaneous estimation of praziquantel (PZQ) and pyrantel pamoate (PP) in the pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase maintained at an ambient temperature with a mobile phase comprising of water: acetonitrile (20: 80) at a flow rate of 1.0 ml/min and UV detection at 220 nm. Results: The retention time of PZQ and PP was found to be 3.897 min and 1.697 min respectively. The method was validated in terms of specificity, accuracy, precision, linearity and robustness as per ICH guidelines. Linearity was obtained in the concentration range of 20–60 μg/ml for both PZQ and PP with correlation coefficients of 0.987 and 0.998 respectively. The accuracy of the method was determined using a recovery test and found as 98.44 % to 100.35 %. All parameters are found to be within the acceptable limit. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise for the simultaneous estimation of PZQ and PP in bulk and tablet dosage form.

Sign in / Sign up

Export Citation Format

Share Document