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.

A NEW STRESS INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND METFORMIN IN BULK AND ITS TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (02) ◽  
pp. 39-46
Author(s):  
Babu D. China ◽  
◽  
C. Madhusudhana Chetty ◽  
Sk. Mastanamma
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise and robust reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Ertugliflozin (ETZ) and metformin (MFN) in bulk and in tablet dosage form. The method was carried out by used Waters (5μm, C18 250 x 4.6 mm) column with mobile phase consists of 0.75 mM sodium dihydrogen orthophosphate buffer pH adjusted to 8.5, with NaOH, and acetonitrile in the ratio of 60:40 v/v, a flow rate of 1.5 mL/min and photodiode detection at 263 nm. The method was validated as per ICH guidelines with different parameters, the mean retention times of ertugliflozin and metformin were found to be 3.5& 2.0 min, respectively. The correlation coefficient values of calibration curves were found to be 0.999 for both ETZ and MFN, respectively. The LOD and LOQ for ertugliflozin and metformin were found to be 0.02-0.06 μg/mL and 17.5-58.3 μg/mL respectively.

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 RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION AND FORCED DEGRADATION STUDIES OF LAMIVUDINE AND RALTEGRAVIR IN SOLID DOSAGE FORM

2018 ◽  
Vol 10 (6) ◽  
pp. 242
Author(s):  
Juluri Krishna Dutta Tejaswi ◽  
R. Govinda Rajan
Keyword(s):  
Correlation Coefficient ◽  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

Objective: A stability indicating reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of the combined tablet formulation of lamivudine (LAM) and raltegravir (RAL) in dosage forms and its API.Methods: Chromatographic separation was achieved on inertsil ODS C18 5 µm (4.6 X 150 mm) using a mobile phase (MP) consisting of a mixture of mixed orthophosphoric acid (OPA): acetonitrile (ACN) in the ratio 50:50 v/v which was determined at 242 nm respectively. Results: The assay of LAM and RAL was performed with tablets, and the % assay was found to be 100.12 and 99.89 which shows that the method is useful for routine analysis. The linearity of LAM and RAL was found to be linear with a correlation coefficient of 0.998 and 0.999, which shows that the method is capable of producing good sensitivity. The retention time of LAM and RAL was 1.99 min and 4.34 min respectively; linearity range was found to lie from 15 µg/ml to 75 µg/ml for LAM, 30 µg/ml to 150 µg/ml for RAL with a correlation coefficient of 0.999 respectively. Forced degradation studies were conducted in acidic, basic, thermal, photolytic and peroxide where all the degradation peaks were monitored.Conclusion: The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of LAM and RAL in bulk and tablet dosage form. Thus the validated economical method was applied for forced degradation study of LAM and RAL tablet.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TAPENTADOL HYDROCHLORIDE IN ITS SOLID DOSAGE FORM

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (01) ◽  
pp. 58-61
Author(s):  
P. P Udapurkar ◽  
S. R. Kamble ◽  
K. R. Biyani ◽  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Validation Data ◽  
Rp Hplc ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

The present paper describes simple and sensitive, reversed phase high performance liquid chromatography (RP-HPLC) method developed for the determination of tapentadol hydrochloride in bulk and in its tablet dosage form. Chromatographic separation was achieved by using phenomenex C18 column, 250×4.6 mm, 5 μm as stationary phase. Mixture of acetonitrile: water (80:20 V/V) was used as the mobile phase and the pH was adjusted into 7.0 using orthophosphoric acid, at a flow rate of 0.7 mL/ min. Tapentadol standard shows maximum absorption in UV at 272 nm. The method was linear over the concentration range of 5-25 μg/mL. The method was validated statistically and recovery study was performed as per ICH guidelines. The analytical recovery obtained was 98-119%. As per validation data it was found that method is specific, robust and precise within the described concentration range. The described RP-HPLC method was successfully employed for the analysis of a commercial brand of tapentadol hydrochloride tablets.

FORCED DEGRADATION STUDIES OF OLMESARTAN MEDOXOMIL AND CHLORTHALIDONE: DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP‑HPLC METHOD

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (03) ◽  
pp. 39-45
Author(s):  
A Sherje ◽  
A. Sonalkar ◽  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Olmesartan Medoxomil ◽  
The United States ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Forced Degradation ◽  
Uv Detector ◽  
Tablet Dosage

A reversed-phase high-performance liquid chromatographic method was developed for the simultaneous determination of olmesartan medoxomil (OLME) and chlorthalidone (CHLOR) in tablet dosage form. The analysis was performed on Inertsil ODS C18 (250 x 4.6 mm, 5 μ) using KH2PO4 phosphate buffer (pH) and acetonitrile as mobile phase in the proportion of 60: 40 v/v at flow rate of 1.0 mL/min. Detection of drugs was carried out in isocratic mode using UV detector at 275 nm. The retention time of OLME and CHLOR was 13.9 ± 0.1 min. and 4.4 ± 0.5 min., respectively and the total run time was 20 min. The method was validated according to the requirements of the United States Pharmacopeia. The percentage recoveries was found to be in the range of 98.9 - 100.7%. The method was successfully applied to the assay of OLME and CHLOR in tablet dosage form.

scholarly journals Analytical Method Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Pyridoxamine Dihydrochloride and Acetylcysteine in Tablet Dosage Form.

2021 ◽  
Vol 23 (06) ◽  
pp. 992-1000
Author(s):  
Sneha S. Ghule ◽  
◽  
Ashpak M. Tamboli ◽  
Snehal D. Patil ◽  
◽  
...  
Keyword(s):  
High Performance ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
System Suitability ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage

A reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Pyridoxamine dihydrochloride and Acetylcysteine in the marketed formulation is developed. Chromatography carried out at 30oc temperature on Agilent Zorbax Bonus-RP (250 x 4.6 mm, 5 µ) coloum. Coloum using a mobile phase 0.1% trifluroacetic acid in water: acetonitrile (80:20v/v) with flow rate 1ml/min (DAD scan at 210nm). Validation parameters such as system suitability, linearity, precision, accuracy are considered as reported International Conference on Harmonization guidelines. The retention times for Pyridoxamine dihydrochloride and Acetylcysteine are 2 min and 3.4 min. The linearity range for Pyridoxamine dihydrochloride and Acetylcysteine is 30-70 µg/ml and 180-420 µg/ml. The %RSD for accuracy was found to be less than 2%. Hence the proposed method was found to be accurate, precise, reproducible, and specific and can be used for simultaneous analysis of these drugs in tablet formulation.

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORM BY RP-HPLC

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (08) ◽  
pp. 12-16
Author(s):  
S Vidyadhara ◽  
◽  
L. S Reddyvalam ◽  
T. Koduri ◽  
P. K. Borra ◽  
...  
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
Correlation Coefficients ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, accurate, precise high-performance liquid chromatographic (HPLC) method has been developed and validated for the simultaneous determination of abacavir sulphate (ABA) and lamivudine (LAM) in combined dosage form. Separation was performed on a C18 column [Agilent ODS UG 5 column, 250 mm x 4.5 mm], with methanol: water (50:50 V/V) isocratic elution using a flow rate of 1mL/min. Good sensitivity was observed with UV detection at 277 nm. After method development, the interference of other active compounds and excipients, repeatability and linearity, were investigated. Retention times of LAM and ABA were found to be 3.3 and 6.3 min, respectively. The method was validated over the range from 2.5-12.5 μg/mL for LAM and 5-25 μg/mL for ABA with correlation coefficients of 0.9997 and 0.9996, respectively. This method was shown to be accurate, robust, selective, linear, and repeatable and can be successfully employed in routine quality control for the simultaneous analysis of ABA and LAM in tablets.

scholarly journals AN INNOVATIVE METHOD DEVELOPMENT AND FORCED DEGRADATION STUDIES FOR SIMULTANEOUS ESTIMATION OF SOFOSBUVIR AND LEDIPASVIR BY RP HPLC

2018 ◽  
pp. 34-41
Author(s):  
B. Anjaneyulu Reddy ◽  
Md. Irshad Alam ◽  
Nazia Khanam ◽  
P. R. Adhakrishnanand
Keyword(s):  
High Performance ◽  
Method Development ◽  
Cost Effective ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Combination Tablet ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Effective Stability

Objective: To develop an innovative, rapid, simple, cost effective, stability indicating reverse phase-high performance liquid chromatography (RP-HPLC) method for simultaneous estimation of ledipasvir (LP) and sofosbuvir (SB) in combination pill dosage form. Methods: The method was developed using C8 column, 250 mm x 4.6 mm, 5mm using mobile section comprising of 0.1% (v/v) orthophosphoric acid buffer at pH 2.2 and acetonitrile in the ratio of 45:55 that was pumped through the column at a flow rate of 0.8 ml/min. Temperature was maintained at 30 °C, the effluents were monitored at 260 nm with the help of usage of PDA detector. Results: The retention time of LP and SB were found to be 2.246 min and 3.502 min. The approach was found to be linear with the variety of 9-36 µg/ml and 40-240 μg/ml for LP and SB respectively, the assay of estimated compounds were found to be 99.65% and 99.73% w/v for LP and SB respectively. Conclusion: The pressured samples changed into analyzed and this proposed a technique turned into determined to be particular and stability indicating as no interfering peaks of decay compound and excipients were observed. Hence, the approach was easy and economical that may be efficiently applied for simultaneous estimation of both LP and SB in bulk and combination tablet system.

scholarly journals RP-HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Hydrochlorothiazide in Combined Dosage Forms

1970 ◽  
Vol 3 (1) ◽  
pp. 49-53 ◽  
Author(s):  
Gaurav Patel ◽  
Sanjay Patel ◽  
Dhamesh Prajapiti ◽  
Rajendra Mehta
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Reversed Phase ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Rp Hplc ◽  
Long Acting

A reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in combine dosage form. Amlodipine Besylate (AML) is a long acting calcium channel blocker and in the treatment of CVS disorder. Hydrochlorothiazide (HCT) is a diuretic and antihypertensive. The mobile phase used was a combination of Water: Methanol (70:30). The detection of the combined dosage form was carried out at 245nm and a flow rate employd was 0.5ml/min. The retention time for Amlodipine Besylate and Hydrochlorothiazide was found to be 6.95 and 2.65 min respectively. Linearity was obtained in the concentration range of 6 to 18μg/ml of Amlodipine Besylate and 6 to 18μg/ml of Hydrochlorothiazide with a correlation coefficient of 0.997 and 0.9974. Detector consists of photodiode array detector; the reversed phase column used was RP-C18 (5 μm size, 250mm, 4.6mm i.d.) at ambient temperature. The developed method was validated according to ICH guidelines and values of accuracy, precision and other statistical analysis were found to be in good accordance with the prescribed values. Thus the proposed method is precise, selective and rapid for simultaneous estimation of Amlodipine Besylate and Hydrochlorothiazide in routine analysis. Key Words: Simultaneous Estimation; Amlodipine Besylate; Hydrochlorothiazide; HPLC. DOI: 10.3329/sjps.v3i1.6798S. J. Pharm. Sci. 3(1): 49-53

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