Development and Validation of new RP-HPLC Method for simultaneous Estimation of Methylcobalamin, Epalrestat and Pregabalin in bulk and Pharmaceutical dosage form

2021 ◽  
pp. 5097-5100
Author(s):  
Krishnaphanisri Ponnekanti ◽  
Sunitha K. ◽  
Ganapaty S.
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Thermal Conditions ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Phase Water ◽  
The Stability

A new rapid, accurate, precise and economical reverse phase high performance liquid chromatographic method has been developed and validated for simultaneous estimation of Methylcobalamin, Epalrestat and Pregabalin in bulk and pharmaceutical dosage form. The separation was accomplished utilizing Agilent C18, 150 x 4.6mm, 5 column at a detection wavelength of 210nm utilizing the mobile phase water and acetonitrile 60: 40 v/v at the flow rate of 0.8ml/min and injection volume of 10µl. The total run time was 6.0 min. Validation discovered the method was specific, rapid, accurate, precise, reliable and reproducible. The calibration curve was linear over the concentration range of 0.37 – 2.25μg/ml of Methylcobalamin, 37.5-225μg/ml of Epalrestat and 37.5-225μg/ml of Pregabalin respectively with correlation coefficient of 0.999. The accuracy was determined by recovery studies and was found to be 99.5-100%. The precision of the results stated that the %RSD was <2%. The limits of detection for Methylcobalamin, Epalrestat and Pregabalin were 0.2, 0.9 and 1.2μg/ml, while the limits of quantification were 0.5, 1.5 and 0.9μg/ml respectively. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed HPLC method. The high recovery confirms the suitability of developed method and can be further used in routine analysis.

scholarly journals VALIDATED RP-HPLC METHOD AND UNIQUE MOBILE PHASE FOR THE SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND VALSARTAN FROM SOLID DOSAGE FORM AND ROSUVASTATIN AND VALSARTAN FROM BULK

2019 ◽  
pp. 156-162
Author(s):  
DYADE GK ◽  
SAWANT RL
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Amlodipine Besylate ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Liquid Chromatographic

Objective: A reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of amlodipine besylate (AD) and valsartan (VAL) in pharmaceutical dosage form, and rosuvastatin (RV) and VAL from the bulk mixture. Method: Chromatographic separation was performed on RP-C18 column. The optimized unique mobile phase (acetonitrile:water and pH adjusted to 4.8 with acetic acid) was pumped at a flow rate of 0.8 ml/min in the ratio of 75:25% v/v, and the eluents were monitored at 245 nm. Results: The assay was performed with tablet and percentage of assay was found to 101.39 for AD and 100.05 for VAL, respectively, and with bulk mixture, percentage of assay was found to 99.58 for RV and 100.32 for VAL, respectively. Linearity was obtained in the concentration range of 1–12 μg/ml for AD, 5–50 μg/mL for VAL, and 2–20 μg/ml for RV. The method was statistically validated and RSD was found to be <2%, indicating high degree of accuracy and precision of the proposed RP-HPLC method. Conclusions: The method suggests usefulness of unique mobile phase during the estimation of two or more multicomponent dosage forms. Due to its simplicity, rapidness, high precision, and accuracy, the proposed RP-HPLC method can be applied for simultaneous determination of AD and VAL in pharmaceutical dosage form, and RV and VAL in bulk mixture.

scholarly journals New Analytical Method Development and Validation for Simultaneous Estimation of Sofosbuvir and Velpatasvir in Bulk and Pharmaceutical Dosage Form by RP-HPLC Method

2020 ◽  
Vol 10 (5) ◽  
pp. 143-148
Author(s):  
T. Hanuman ◽  
T. Sivakkumar ◽  
S. Sridhar
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the simultaneous determination Sofosbuvir and Velpatasvirin pharmaceutical dosage form. The column used was Kromosil C18(150mm x 4.6 mm, 5mm)in isocratic mode, with mobile phase containing phosphate buffer andacetonitrile(70:30v/v). The buffer is prepared by adding 1.41gm of sodium dihyrogen ortho phosphate in a 1000ml of volumetric flask add about 900ml of milli-Q water added and degas to sonicate and finally make up the volume with water then pH adjusted to 3.5 with dil. orthophosphoric acid solution. The flow rate was 1.0ml/ min and effluents were monitored at 260 nm. The retention times of Sofosbuvir and Velpatasvirwere found to be 2.404min and 2.986 min, respectively. The linearity for Sofosbuvir and Velpatasvirwere in the range of 40-240µg/ml and 10-60 µg/ml respectively. The recoveries of Sofosbuvir and Velpatasvirwere found to be 99.64% and 99.25%, respectively. The proposed method was validated and successfully applied to the estimation of Sofosbuvir and Velpatasvirin combined tablet dosage forms. Keywords: Sofosbuvir, Velpatasvir, Validation, Buffer and ICH Guidelines.

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 SIMULTANEOUS ESTIMATION, VALIDATION, AND FORCED DEGRADATION STUDIES OF BETAHISTINE DIHYDROCHLORIDE AND DOMPERIDONE IN A PHARMACEUTICAL DOSAGE FORM USING RP-HPLC METHOD

2018 ◽  
Vol 11 (10) ◽  
pp. 125
Author(s):  
Vaishali Mistry ◽  
Rohan Mishra
Keyword(s):  
Hplc Method ◽  
Base Hydrolysis ◽  
Simultaneous Estimation ◽  
Forced Degradation ◽  
Uv Detector ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Betahistine Dihydrochloride ◽  
The Stability

Objective: This study describes the stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of betahistine dihydrochloride and domperidone in pharmaceutical dosage forms.Methods: The proposed RP-HPLC method was developed using Shimadzu Prominence-i LC-2030 HPLC system equipped with UV detector and chromatographic operation was carried on Shim-pack C18 (250 mm×4.6 mm, 5 μ) column at a flow rate of 1 ml/min and the run time was 10 min. The mobile phase consisted of methanol and water in the ratio of 80:20% v/v and eluents were scanned using a UV detector at 244 nm.Results: The retention time of betahistine dihydrochloride and domperidone was found to be 2.3 and 3.6 min, respectively. A linearity response was observed in the concentration range of 9.6 μg/ml–22.4 μg/ml for betahistine dihydrochloride and 6–14 μg/ml for domperidone, respectively. Limit of detection and limit of quantification for betahistine dihydrochloride were 0.52 μg/ml and 1.58 μg/ml and for domperidone are 0.64 μg/ml and 1.94 μg/ml, respectively.Conclusion: The stability-indicating method was developed by subjecting drugs to stress conditions such as acid and base hydrolysis, oxidation, photo and thermal degradation, and degraded products formed were resolved successfully from samples.

SIMULTANEOUS DETERMINATION OF FROVATRIPTAN, ALMOTRIPTAN AND ZOLMITRIPTAN IN COMBINED PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (09) ◽  
pp. 27-32
Author(s):  
V. S Reddy ◽  
◽  
T. E. G. K. Murthy ◽  
N Usha Rani ◽  
R. S Rao ◽  
...  
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Liquid Chromatographic Method ◽  
Liquid Chromatographic

A simple, precise, accurate, reproducible, robust reverse phase high-performance liquid chromatographic method was developed for the simultaneous estimation of frovatriptan, almotriptan and zolmitriptan in bulk and pharmaceutical dosage forms. The method was validated as per ICH and FDA guidelines. Analysis of the drugs was performed on Phenomenex Chromosil C-18 (250 x 4.6 mm, 5 mc) column, in an isocratic mode employing methanol, acetonitrile and THF in the ratio of 46:50:04 (v/v/v) as mobile phase. UV-visible detector at 269 nm was found to be suitable for detection. Linearity was observed in the range of 40-100 ppm.The % recovery was found to be 99.51, 99.69 and 99.34 for frovatriptan, almotriptan and zolmitriptan respectively. The % RSD values for method precision was found to be 0.86, 0.65 and 1.28 for frovatriptan, almotriptan and zolmitriptan respectively. Limit of quantification (LOQ) and limit of detection (LOD) values were found to be 0.15, 0.08 and 0.09 ppm. and 0.05, 0.02, 0.03 for frovatriptan, almotriptan and zolmitriptan respectively.

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 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 Development and Validation of a Micellar High-Performance Liquid Chromatographic Method for Determination of Risedronate in Raw Material and in a Pharmaceutical Formulation: Application to Stability Studies

2010 ◽  
Vol 93 (4) ◽  
pp. 1228-1235 ◽  
Author(s):  
Mohamed Walash ◽  
Mohamed Metwally ◽  
Manal Eid ◽  
Rania El-Shaheny
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Sodium Dodecyl ◽  
Oxidative Degradation ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Raw Material ◽  
Forced Degradation ◽  
The Stability ◽  
Liquid Chromatographic

Abstract A micellar HPLC method was developed for analysis of the antiosteoporosis drug risedronate. The analysis was carried out using a 250 4.6 mm id, 5 m particle size C18 Waters Symmetry column. The mobile phase consisted of 0.02 M sodium dodecyl sulfate + 0.3 triethylamine + 10 n-propanol, prepared in 0.02 M orthophosphoric acid. The pH of the mobile phase was adjusted to pH 6.0, and it was pumped at a flow rate of 0.7 mL/min with UV detection at 262 nm. The method showed good linearity in the range of 280 g/mL, with an LOD of 0.40 g/mL (1.31 106 M) and an LOQ of 1.21 g/mL. The suggested method was successfully applied for the analysis of risedronate in raw material and a tablet formulation, with average recoveries of 99.91 1.30 and 101.52 0.30, respectively. The stability-indicating capability of the proposed method was proved using forced degradation. By changing the pH of the mobile phase to 4.0, the oxidative degradation product could be separated from risedronate.

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

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.

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