scholarly journals VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TELMISARTAN AND HYDROCHLOROTHIAZIDE CONTENT IN BULK AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
Vol 9 (12) ◽  
pp. 136-146
Author(s):  
P. Santosh Kumar ◽  
◽  
Wuchen a ◽  
Wang Lei ◽  
Zaheer Abbas ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Gradient Flow ◽  
Oral Dosage ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Column Temperature ◽  
Stability Indicating

A simple, accurate, precise and rapid stability indicating reverse phase High performance chromatography method was used for estimation of Telmisartan and Hydrochlorothiazide in bulk and fixed-dose combination solid oral dosage form. The proposed analytical method has been validated for specificity, Linearity, Accuracy, Precision and Robustness. The chromatography was achieved in a GL science, Inertsil C8 (Length 125x Diameter 4.0mm Particle size 5µm) column with gradient flow. The optimal chromatographic condition consisted of mobile phase pH 3.0 at a flow rate of 1.2mL/min, with a column temperature of 40°C, run time 14 minutes and detector wavelength of 270nm.

STABILITY INDICATING HIGH PERFORMANCE THIN-LAYER CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND LORATADINE IN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (08) ◽  
pp. 44-51
Author(s):  
R. S. Sakhare ◽  
◽  
S. S. Pekamwar ◽  
T. V. Gitte
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Degradation Products ◽  
Stability Study ◽  
Simultaneous Estimation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Aluminum Plates ◽  
Ambroxol Hydrochloride

A simple, sensitive, accurate, precise and rapid stability indicating HPTLC method for simultaneous determination of ambroxol hydrochloride and Loratadine in pharmaceutical dosage form has been developed. The study was performed on TLC aluminum plates precoated with silica gel 60F254 using chloroform: methanol (9:1v/v) as the mobile phase. This system gives compact and dense spots for both ambroxol hydrochloride (Rf value of 0.36±0.003) and loratadine (Rf value of 0.68±0.002). Densitometric analysis of both drugs was carried out in the reflectance absorbance mode at 216 nm. The coefficient of correlation data for the calibration plots showed a good linear relationship with R2 = 0.997 ± 1.1224 in the range of 600-3600 ng for ambroxol hydrochloride and R2 = 0.998 ± 0.0935 in the range of 50-300 ng for loratadine. The method was validated according to ICH guidelines for specificity, precision, robustness and recovery. Stability study shows that the chromatograms of samples from its degradation products were well resolved with significant Rf value.

scholarly journals Qbd Based RP-HPLC Method Development and Validation for Simultaneous Estimation of Amlodipine Besylate and Lisinopril Dihydrate in Bulk and Pharmaceutical Dosage Form

2021 ◽  
pp. 143-164
Author(s):  
Sachin A. Babar ◽  
Sudhakar L. Padwal ◽  
Madhusudhan T. Bachute
Keyword(s):  
Flow Rate ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Chromatography Method ◽  
Mobile Phase Flow Rate ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms

The objective of this experiment was to develop and validate a simple, robust, and accurate QbD based Reverse-Phase High-Performance Liquid Chromatography method for Simultaneous estimation of Amlodipine besylate and Lisinopril dihydrate in bulk and Pharmaceutical Dosage form. A box-Behnken design was employed for optimizing the mobile phase, flow rate and pH of buffer, the optimized chromatographic conditions were Phosphate buffer: Methanol (25: 75 v/v), pH of buffer: 6.5 and flow rate: 1mL/min. Furthermore formulation injected and observed that the additives do not interfere with the peak of Amlodipine besylate and Lisinopril dehydrate. Both drugs are well resolved and Retention times were found to be 2.332 min and 3.584 min respectively. Linearity was observed in the concentration range of 10 μg to 50 μg/mL (r2=0.999). The accuracy range was 99.75 to 100.04%. Intra-day and Inter-day precision was found to be less than 2% RSD. The proposed method was useful for the best analysis of Amlodipine besylate and Lisinopril dihydrate in Bulk, pharmaceutical dosage forms and was successfully applied to routine analysis.

scholarly journals A Stability Indicating RP-HPLC Method Validation for Simultaneous estimation of Metformin HCl and Canagliflozin in Pharmaceutical Dosage Form

2021 ◽  
pp. 180-192
Author(s):  
Darshak Patel ◽  
Ujashkumar Shah ◽  
Jayvadan Patel ◽  
Hirak Joshi ◽  
Darshana Patel ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Fixed Dose ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Validation Parameters ◽  
Metformin Hcl

Aims: Canagliflozin and Metformin HCl is a new drug combination for the treatment of Diabetes Mellitus which is one of the oldest and lethal diseases of the mankind. Aim of the research work was to develop and validate novel, rapid, sensitive, specific, robust stability indicating analytical method for the simultaneous estimation of Canagliflozin and Metformin HCl in the pharmaceutical dosage form as fixed dose formulation. Study Design: Method development and validation was performed as recommended in ICH guideline “Validation of analytical procedures: Test and Methodology Q2(R1)”. Methodology: Method develop with chromatographic parameters as C18 column (250mm×4.6 mm, 5mm particle size), HPLC system with PDA detector and mobile phase contained a mixture of Phosphate Buffer pH 5.0 and Acetonitrile (60:40 v/v). The flow rate was set to 1ml/min with responses measured at 290 nm, injection volume was 20 µl, and run time of 15 mins. Results: The retention time of Metformin Hydrochloride and Canagliflozin was 5.4 min and 7.6 min respectively with resolution of 7.0. Linearity was established in the range of 10-30 µg/ml for Metformin Hydrochloride and 0.5-1.5 µg/ml for Canagliflozin with correlation coefficients more than 0.999. The percentage recoveries were between (98.62-101.22%) and (98.68-101.27%) for Metformin Hydrochloride and Canagliflozin respectively. Validation parameters were evaluated according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The forced degradation studies were performed by using HCl, NaOH, H2O2, thermal and UV radiation. The developed method was successfully applied for the quantification and hyphenated instrumental analysis. Conclusion: Significance of developed method is that it can be utilize for routine or unknown sample analysis of assay of Metformin HCl and Canagliflozin in pharmaceutical dosage form developed by various Pharmaceutical Industry.

scholarly journals STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND DAPAGLIFLOZIN IN API AND PHARMACEUTICAL DOSAGE FORM

2021 ◽  
Vol 12 (8) ◽  
pp. 52-57
Author(s):  
Chaitali R Dhale ◽  
Rao J R
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Tablet Dosage

A simple and specific stability indicating reversed-phase high-performance liquid chromatography technique has been developed and validated for the concurrent estimation of metformin hydrochloride and dapagliflozin in bulk and pharmaceutical dosage form. The ideal conditions were established for the study or analysis of the drug such as chromatographic separation was carried out on THERMO fisher ODS C18 column containing mobile phase of water and acetonitrile 65:35 % v/v of pH 6.8 adjusted with 0.1 % ortho phosphoric acid at a flow rate of 1 ml/minutes detected wavelength at 240 nm. The retention time was found to be 2.13 minutes and 5.41 minutes for metformin hydrochloride (MET) and dapagliflozin (DAPA) respectively. The proposed method was found to be linear in the concentration range of 100-600 ug/ml for MET (R2=0.9999) and 1-6 ug/ml for DAP (R2=0.9996), respectively. Method was validated according to ICH guidelines. Co-relation coefficients for both the drugs were found to be less than one. The mean % recoveries obtained were found to be 99.06-100.32% for metformin and 99.1-100.18% for dapagliflozin respectively. Stress testing is carried out for both drugs in acid, base, peroxide, photolytic and thermal degradation. The developed method can be effectively applied for routine analysis in simultaneous determination of metformin hydrochloride and dapagliflozin in bulk and combined tablet dosage form.

scholarly journals STABILITY-INDICATING REVERSED-PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS ESTIMATION OF DARUNAVIR AND RITONAVIR

2016 ◽  
pp. 66
Author(s):  
Sindu Priya Dasyam ◽  
Gowri Sankar D ◽  
Masthanamma Sk
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
High Performance ◽  
Limit Of Detection ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating

<p>ABSTRACT<br />Objective: The main objective of the proposed study was to develop and validate a new stability indicating reverse phase high performance liquid<br />chromatography method for the simultaneous estimation of darunavir (DRV) and ritonavir (RTV).<br />Methods: The method was optimized using Atlantis C18 column (50 mm×4.6 mm, 5 µm, Waters Corporation, Milford, USA). Acetonitrile and water<br />were used as mobile phase in the proportion of 60:40. The flow rate was 0.8 ml/minutes and the effluent was monitored at 230 nm.<br />Results: The retention time of DRV and RTV was 3.15 minutes and 4.59 minutes, respectively. The method was precise as it showed a % relative<br />standard deviation of &lt;2%. The percentage recoveries of both the drugs DRV and RTV were 99.8-100.01% and 99.5-99.97%, respectively. The<br />linearity of DRV and RTV was in the range of 40-120 and 4-20 µg/ml, respectively. Calibration curve showed good linearity and range. The correlation<br />coefficient of DRV and RTV was 0.999 each. Moreover, the results obtained for limit of quantification, limit of detection, robustness, and ruggedness<br />were well within the acceptance criteria.<br />Conclusion: The proposed method was found to be simple, rapid, accurate, precise, and stability indicating. It was found to be economical and suitable<br />for simultaneous determination of DRV and RTV which is can also be applied for pharmaceutical dosage form.<br />Keywords: Darunavir, Ritonavir, Reversed-phase-high performance liquid chromatography, Simultaneous estimation, Forced degradation.</p>

scholarly journals A Stability Indicating RP-HPLC Method Validation for Simultaneous Estimation of Metformin HCl, Dapagliflozin and Saxagliptin in Pharmaceutical Dosage Form

2021 ◽  
pp. 754-767
Author(s):  
Darshak Patel ◽  
Ujashkumar Shah ◽  
Jayvadan Patel ◽  
Darshana Patel ◽  
Pavan Patel
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Method Development ◽  
Fixed Dose ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Validation Parameters ◽  
Metformin Hcl

Aims: Metformin HCl, Dapagliflozin and Saxagliptin is a new drug combination for the treatment of Diabetes Mellitus which is one of the oldest and lethal diseases of mankind. Aim of the research work was to develop and validate novel, rapid, sensitive, specific, robust stability indicating analytical method for simultaneous estimation of: Metformin HCl, Dapagliflozin and Saxagliptin in pharmaceutical dosage form as fixed dose formulation. Study Design: Method development and validation was performed as recommended in ICH guideline “Validation of analytical procedures: Test and Methodology Q2 (R1)”. Methodology: Method develop with chromatographic parameters as C18 column (250mm×4.6 mm, 5mm particle size), HPLC system with PDA detector and mobile phase contained a mixture of Phosphate Buffer pH 3.5 and Acetonitrile (80:20 v/v) + 1 ml triethylamine per 100 ml mobile phase. The flow rate was set to 1 ml/min with responses measured at 265 nm, injection volume was 20 µl, and run time of 15 mins. Results: The retention time of Metformin HCl, Dapagliflozin and Saxagliptin was 5.8 min, 6.8 mins and 8.4 min respectively with resolution of 3.5 between Metformin HCl and Dapagliflozin and 4.5 between Dapagliflozin and Saxagliptin. Linearity was established in the range of 250-1500 µg/ml for Metformin HCl, 1.25-7.5 µg/ml for Dapagliflozin and Saxagliptin with correlation coefficients more than 0.999. The percentage recoveries were between 98.39-101.66 for Metformin HCl, 99.01-101.77 for Dapagliflozin and 98.88-101.87 for Saxagliptin Validation parameters were evaluated according to the International Conference on Harmonization (ICH) Q2 R1 guidelines. The forced degradation studies were performed by using HCl, NaOH, H2O2, thermal and UV Radiation. The developed method was successfully applied for the quantification and hyphenated instrumental analysis. Conclusion: Significance of developed method is that it can be utilize for routine or unknown sample analysis of assay of Metformin HCl, Dapagliflozin and Saxagliptin in pharmaceutical dosage form developed by various Pharmaceutical Industry.

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 NOVEL NOVEL STABILITY-INDICATING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC ASSAY METHOD FOR SIMULTANEOUS ESTIMATION OF HYDROCORTISONE AND TETRACYCLINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

2019 ◽  
pp. 255-258
Author(s):  
MUNI SAI VARAGANTI ◽  
PRASANTHI CHENGALVA ◽  
ARUNA GUNDALA
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Simultaneous Estimation ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

Objective: A combination of hydrocortisone and tetracycline as topical ophthalmic ointment is used for skin irritations, eye infections, inflammation, skin infections, acne, and rashes. The objective of the current work is to a simple, rapid, accurate, and precise, stability-indicating reverse-phase liquid chromatographic method was developed for the simultaneous estimation of hydrocortisone and tetracycline in bulk and pharmaceutical dosage form. Methods: The separation was carried out in Discovery C18 column (250 × 4.6 mm, 5 μm) using mobile phase ratio of water (pH 2.2 adjusted with orthophosphoric acid):acetonitrile (40:60 v/v) in an isocratic elution mode with a flow rate of 1.0 ml/min at detection wavelength of 244 nm. The injection volume was 10 μl and the column temperature was set at 30°C. Results: The retention time for hydrocortisone and tetracycline was found to be 2.214 ± 0.001 min and 3.497 ± 0.001 min, respectively. Calibration curves were linear (r2=0.999) at a concentration range of 2.5–15 mg/ml for both hydrocortisone and tetracycline. The percentage recoveries were found to be 99.13–99.67% for hydrocortisone and 99.39–99.61% for tetracycline. Relative standard deviation was found to be 0.3% for both the drugs. Limit of detection and limit of quantification values of hydrocortisone and tetracycline were found to be 0.09 μg/ml and 0.27 μg/ml and 0.17 μg/ml and 0.52 μg/ml, respectively. The drugs were subjected to various stress conditions and found no interference of degraded products peak at the retention times of analyte peaks. Conclusion: A rapid and accurate reverse-phase high-performance liquid chromatographic method was developed for simultaneous estimation of hydrocortisone and tetracycline, and the method was validated as per the International Council for Harmonization guidelines. Hence, the developed method can be successfully applied for the simultaneous estimation of hydrocortisone and tetracycline in bulk and ointment formulation.

Sign in / Sign up

Export Citation Format

Share Document