scholarly journals STABILITY-INDICATING METHOD DEVELOPMENT AND VALIDATION OF ITRACONAZOLE AND TERBINAFINE HCL IN BULK AND PHARMACEUTICAL TABLET DOSAGE FORM

2019 ◽  
pp. 51-55 ◽  
Author(s):  
DEVYANI M RODE ◽  
Dr. NUTAN RAO
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Pharmaceutical Tablet ◽  
The Stability ◽  
Tablet Dosage ◽  
Terbinafine Hcl

Objective: The objective of the present work was to develop and validate the stability-indicating method for the simultaneous estimation of itraconazole and terbinafine HCl in bulk and pharmaceutical tablet dosage form by reversed-phase high-performance liquid chromatography (HPLC). This combination of drugs is not reported for simultaneous HPLC analysis as of now. Methods: The analysis of the developed method was carried on Shimadzu LC Prominence-i 2030 model with Lab Solution software and the separation was done on Shim-pack C18 GIST (250 mm×50 mm, 5 μm) column with a flow rate of 1.2 ml/min and run time of 12 min. The injection volume was 10 μl and mobile phase consisted of acetonitrile and 0.1% triethylamine in the ratio of 90:10 and 225 nm was used as a detection wavelength. Results: The retention time was found to be 3.464 min and 8.705 min for itraconazole and terbinafine HCl, respectively. The calibration curve was found to be linear and r2 values were 0.9989 and 0.9995 for itraconazole and terbinafine HCl, respectively. Conclusion: The stability-indicating method was developed by subjecting itraconazole and terbinafine HCl marketed formulation to various stress conditions such as acidic, basic, oxidative, thermal, and water hydrolysis degradation conditions and the degraded product peaks were well resolved from sample peaks.

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 A Novel Stress Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Velpatasvir and Sofosbuvir in Bulk and Its Tablet Dosage Form

2019 ◽  
pp. 1-10 ◽  
Author(s):  
D. Chinababu
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Detection Range ◽  
Rp Hplc ◽  
Tablet Dosage

Aim: The objective of the study was simplest, accurate, precise and robust reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Velpatasvir (VEL) and Sofosbuvir (SOF) in the bulk and its tablet dosage form. Study Design: The Quantitative and Qualitative estimation and designed forced degradation study of Velpatasvir & Sofosbuvir by RP-HPLC. Place and Duration of Study: The study was carried at Santhiram College of Pharmacy and time taken 4 months. Method: The method was attained by used Waters( 5µm, C18 250 x 4.6 mm) column with mobile phase consists of  0.5 mM disodium hydrogen phosphate buffer pH adjusted to 6.5, with Orthophosphoric acid and Methanol in the ratio of 78:22 v/v, a flow rate of 1.0 mL/min and ultraviolet detection at 285 nm. Results: The method was validated as per ICH guidelines with different parameters, the mean retention times of VEL and SOF were found to be 2.8 & 4.7 min respectively. The resolution between VEL and SOF was found to be 10.66. The Correlation coefficients for calibration curves within the detection range of 32.5 - 97.5 and 125 - 375 µg/mL were 0.999 for VEL and SOF respectively. The LOD and LOQ for VEL and SOF were found to be 0.0068-0.029 µg/mL and 0.104-0.342 µg/mL respectively. Conclusion: The results were indicated that the developed method was used for the routine analysis of VEL & SOF combined form in bulk and its commercial formulation. To the best of our knowledge, there was no method of RP-HPLC for the determination of VEL alone or in combination with SOF molecule.

scholarly journals Stability-indicating Reversed Phase-Ultra Performance Liquid Chromatography Method Development and Validation for Simultaneous Determination of Encorafenib and Binimetinib in Formulation

2020 ◽  
pp. 488-494
Author(s):  
Taduvai Venkata Raveendranath ◽  
Rajaiah Thangaraj Saravanakumar ◽  
Anjana Male
Keyword(s):  
Method Development ◽  
Detection System ◽  
Ultra Performance Liquid Chromatography ◽  
Reversed Phase ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Stability Indicating Method ◽  
Liquid Chromatography Method

A simple, accurate and precise stability indicating method was developed for the simultaneous estimation of the encorafenib (ECRB) and binimetinib (BMTB) in a dosage form by UPLC. Chromatographic elution was processed through a HSS C18 (100 x 2.1 mm, 1.8m) reverse phase column and the mobile phase composition of 0.01N KH2PO4 buffer (3.5 pH) and acetonitrile in the proportion of 55:45 was processed thru a column at a flow rate of 1.0 ml/min. Temperature of the column oven was kept at 30.0°C and the wavelength maximum of detection system was set to 294 nm. Retention times of ECRB and BMTB were found to be 0.767 min and 1.130 min respectively. Repeatability of the method was determined in the form of %RSD and findings were 0.3 and 0.6 for ECRB and BMTB respectively. The percentage recovery of the method was found to be 99.59% and 99.70% for ECRB and BMTB respectively. LOD, LOQ values obtained from regression equations of ECRB and BMTB were 0.51, 1.55mg/ml and 1.47, 4.44 mg/ml respectively. Regression equation of ECRB was y = 6684.x + 18102 and BMTB was y = 13118x + 2159. Two analytes were subjected for acid, peroxide, photolytic, alkali, neutral and thermal degradation studies and the results shown that the percentage of degradation was found between 0.76% and 6.88%. Retention times and total run time of two drugs were decreased and the developed method was simple and economical. So, the developed method can be adopted in industries as a regular quality control test for the quantification of ECRB and BMTB.

scholarly journals Development and validation of stability-indicating RP-UPLC method for simultaneous estimation of thiocolchicoside and aceclofenac in combined dosage form

2014 ◽  
Vol 3 (7) ◽  
pp. 296-300 ◽  
Author(s):  
Paramasivam Balan ◽  
Nagappan Kannappan
Keyword(s):  
Dosage Form ◽  
Pharmaceutical Journal ◽  
Detector Response ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Stability Indicating ◽  
The Stability ◽  
Development And Validation ◽  
Tablet Dosage

A stability indicating RP-UPLC method was developed and validated for the simultaneous determination of Thiocolchicoside (TCC) and Aceclofenac (ACF) in tablet dosage form. The chromatographic separation was carried out by Thermo Scientific UPLC Instrument, Accela 1250 Pump, auto sampler with PDA detector, using column Thermo Scientific hypersil gold C18, (50 x 2.1mm) particle size 1.9µm using 5% ammonium acetate buffer and methanol in the ratio of 40:60, pH was adjusted to 5 with ortho phosphoric acid as mobile phase at a flow rate of 250 µl/min with the detection at 276nm. The run times of the TCC and ACF were about 0.697 and 1.125 minutes, respectively. The detector response is linear from 4.8 µg/ml to 7.2 µg/ml and 63.8 µg/ml to 96 µg/ml concentrations for TCC and ACF respectively. The linear regression equation was found to be y = 20620x-677.68 (r2 = 0.9996) for TCC and y= 50931x-319.3 (r2 = 0.9997) for ACF. The detection limit and quantification limit was 0.076µg and 0.23µg for TCC and 0.27µg and 0.71µg for ACF. The percentage of assay of TCC and ACF were about 99.50% and 99.96% respectively. The stability indicating capability was established by forced degradation experiments. The method was satisfactorily validated as per the ICH guidelines.DOI: http://dx.doi.org/10.3329/icpj.v3i7.19078 International Current Pharmaceutical Journal, June 2014, 3(7): 296-300

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