Development and Validation of RP-HPLC Method for Quantitation of Clarithromycin in Matrix Tablet Dosage Form

This study was aimed to develop a simple, sensitive and rapid procedure for the analysis of clarithromycin in pure as well as in matrix tablet dosage form by using RP-HPLC method. The chromatographic separation was achieved by a reversed phase C18 column (150 mm length × 4.6 mm i.d., 5 ?m particle size) in an isocratic mode with mobile phase comprising of acetonitrile and 0.035 M potassium dihydrogen phosphate (pH 4.4 ± 0.017) in a ratio of (55: 45, v/v). The eluent was pumped at a flow rate of 0.6 ml/min and the effluent was monitored using UV detector at 210 nm. The method was validated according to the ICH guidelines with respect to linearity, precision, accuracy, selectivity, specificity, ruggedness and robustness. It was found to be linear over the concentration range of 320- 480 ?g/ml (R2= 0.9993) with detection limit of 0.04 ?g/mL. Considering the specifications of this method, the system was found to be suitable for rapid and routine analysis of clarithromycin in pure and matrix tablet dosage form.Dhaka Univ. J. Pharm. Sci. 16(1): 69-75, 2017 (June)

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Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v10i4.4217 ◽

2020 ◽

Vol 10 (4) ◽

pp. 97-101

Author(s):

Mithun Rudrapal ◽

Nazim Hussain

Keyword(s):

Dosage Form ◽

Method Development ◽

Reversed Phase ◽

Hplc Method ◽

Pharmaceutical Dosage Forms ◽

Average Percentage ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

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Development and Validation of RP-HPLC Method for Estimation of Teneligliptin and its Impurity in Tablet

International Journal of Pharmaceutical Sciences Review and Research ◽

10.47583/ijpsrr.2021.v69i02.019 ◽

2021 ◽

Vol 69 (02) ◽

Author(s):

Bhoomi Dineshkumar Patel ◽

Nidhi J. Dharsandiya ◽

Ankit Chaudhary

Keyword(s):

Present Method ◽

Mobile Phase ◽

Potassium Dihydrogen Phosphate ◽

Hplc Method ◽

Simultaneous Estimation ◽

Dihydrogen Phosphate ◽

Potassium Dihydrogen ◽

Rp Hplc ◽

Development And Validation ◽

Tablet Dosage

The objective of the study is a simple, precise and accurate stability RP-HPLC method has been developed and subsequently validated for the estimation of Teneligliptin and its impurity in tablet formulation. The adequate separation was carried out using Grace Smart C18 column (250mm x 4.6mm, 5?m particle size), mixture of 0.05M Potassium dihydrogen phosphate PH 4.0 and Acetonitrile 80:20 % v/v as a mobile phase with a flow rate of 1 ml/min and the effluent was monitored at 242 nm using PDA detector. The retention time of Teneligliptin, Impurity B and Impurity G were 7.443 min, 6.650 min and 8.473 min respectively. Linearity for Teneligliptin, Impurity B and Impurity G were found in the range of 500-3000 µg/ml (R2 = 0.998), 5-15 µg/ml (R2 = 0.994) and 5-15 µg/ml (R2 = 0.998) respectively. The accuracy of the present method was evaluated at 50%, 100% and 150%. The % recoveries of drug were found to be in range of 99.315 ± 0.283 for Teneligliptin. Precision studies were carried out and the RSD values were less than two. The method was found to be robust. The proposed method was found to be specific, accurate, precise and robust can be used for simultaneous estimation of these drugs in tablet dosage form.

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Validated stability-indicating RP-HPLC method for simultaneous estimation of cilnidipine and chlorthalidone in tablet dosage form

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v11ispl4.4495 ◽

2020 ◽

Vol 11 (SPL4) ◽

pp. 2435-2441

Author(s):

Ashok B. Patel ◽

Amitkumar J. Vyas ◽

Shital Faldu ◽

Arvind N Lumbhani ◽

Nikunj J. Patel ◽

...

Keyword(s):

Phosphoric Acid ◽

Dosage Form ◽

Potassium Dihydrogen Phosphate ◽

Hplc Method ◽

Simultaneous Estimation ◽

Dihydrogen Phosphate ◽

Potassium Dihydrogen ◽

Rp Hplc ◽

Tablet Dosage ◽

Ich Guideline

A novel, simple, specific, accurate & precise stability-indicating Gradient reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous estimation of Cilnidipine & Chlorthalidone in tablet dosage form, validated as per ICH guideline. The separation was achieved on Inertsil ODS column (250 mm x 4.6 mm, 5 μm) in a gradient mode. The mobile phase consisted of Methanol, 0.025 M Potassium dihydrogen phosphate Buffer pH 5.5 adjusted by 10% v/v Ortho Phosphoric Acid (50:50 v/v) (Solution A) and Acetonitrile, 0.025 M Potassium dihydrogen phosphate Buffer pH 5.5 adjusted by 10%v/v Ortho Phosphoric Acid (75:25 v/v) (Solution B), gradient programming for 20 min at 1 ml/min rate of flow and response was detected at 225 nm. The retention time was found to be 3.580 min and 12.606 mins for Chlorthalidone and Cilnidipine, respectively. The method is validated according to ICH guideline, which includes linearity, specificity, accuracy, precision and robustness. Linearity was obtained over the concentration range of 10-60 μg/ml for Cilnidipine and 6.25-37.5 μg/ml for Chlorthalidone, had a regression coefficient (r2) almost 0.9966. The % Recovery was found to be 99.63-100.59 % and 100.24-100.51 % for Cilnidipine and Chlorthalidone, respectively. The method was found to be specific enough to separate all degradation products from the active compound. Drug samples were exposed to various stress conditions like photolysis, oxidation, heat conditions, and hydrolysis (acidic and alkaline), there was no interference of any degradants and excipient in the determination of drugs so that methods can be successfully applied for routine QC analysis.

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

INDIAN DRUGS ◽

10.53879/id.54.01.10703 ◽

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.

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A New Stability Indicating RP-HPLC Method for Determination of Chlorthalidone, Telmisartan and Cilnidipine in Bulk and Tablet Dosage Form

International Journal of PharmTech Research ◽

10.20902/ijptr.2019.130106 ◽

2020 ◽

Vol 13 (1) ◽

pp. 44-51

Author(s):

S.Afreen Sultana ◽

Patta. Salomi ◽

T. VimalakKannan ◽

K.Ravindra Reddy

Keyword(s):

Mobile Phase ◽

Dosage Form ◽

Potassium Dihydrogen Phosphate ◽

Hplc Method ◽

Dihydrogen Phosphate ◽

Potassium Dihydrogen ◽

Stability Indicating ◽

Rp Hplc ◽

Tablet Dosage

In present study, accurate, precise, rapid and sensitive stability indicting HPLC-UV method has been established for quantification of Telmisartan, Cilnidipine and Chlorthalidone simultaneously in Tablet and bulk. Telmisartan, Cilnidipine and Chlorthalidone were resoluted on Sunsil C18 column (4.6mmx250mm; 5μm) using mobile phase containing Acetonitrile and Potassium dihydrogen phosphate in 50:50(v/v) ratio with flow rate of 1ml/min at 238 nm. Concentrations were linear over the range of 40-120 μg/ml for Telmisartan, 10-30 μg/ml for Cilnidipine and 6.25-18.75 μg/ml for Chlorthalidone. The percentage recovery was found to be 99.70-100.51% for Telmisartan, 98.41-100.49% for Cilnidipine and 99.34-100.48% for Chlorthalidone. % RSD for peak area was 0.069% for Telmisartan, 0.058% for Cilnidipine and 0.057% for Chlorthalidone shows that the proposed method is precise. Force-degradation studies have not shown any observable change in the results and hence the proposed method is stability indicating and hence the method is suitable for routine analysis of Telmisartan, Cilnidipine and Chlorthalidone in bulk and tablet dosage form.

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Development and validation of a fast and simple RP-HPLC method for the determination of diosmin and hesperidin in combined tablet dosage form

Macedonian Journal of Chemistry and Chemical Engineering ◽

10.20450/mjcce.2018.1448 ◽

2018 ◽

Vol 37 (2) ◽

Cited By ~ 1

Author(s):

Marjan Piponski ◽

Tanja Bakovska Stoimenova ◽

Marina Topkoska ◽

Stefan Stefov ◽

Magdalena Piponska ◽

...

Keyword(s):

Retention Time ◽

Reversed Phase ◽

Hplc Method ◽

Uv Detector ◽

Rp Hplc ◽

Validation Parameters ◽

Time Cycle ◽

Development And Validation ◽

Tablet Dosage

A fast, simple, accurate and robust reversed phase HPLC method for the simultaneous determination of two flavonoids, hesperidin and diosmin, in combined tablets was developed and validated. This method uses a short C8 column with dimensions of 75 mm × 4 mm with 5 µm particles thermostated at 30 °C, and a mobile phase composed of formic acid (pH 4.1 and 0.05%, V/V) and methanol (58:42, V/V), delivered at a flow rate of 1.2 ml/min, with UV detector signal monitoring at 280 nm and an injection volume of 5 µl. These chromatographic conditions yielded chromatograms with symmetric peaks of hesperidin, eluting at a ~2 min retention time, and diosmin, at a ~4.5 min retention time, with a total run time cycle of 6 min. The method validation parameters confirmed excellent values for accuracy, linearity and reproducibility. This method is suitable for routine analysis in pharmaceutical and food quality control laboratories.

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Simultaneous Estimation and Validation of Tenofovir Disoproxil Fumarate, Emtricitabine and Efavirenz by RP-HPLC Method in Combined tablet Dosage Form

Current Pharmaceutical Analysis ◽

10.2174/1573412914666180208152021 ◽

2019 ◽

Vol 15 (6) ◽

pp. 561-567 ◽

Cited By ~ 1

Author(s):

Mehdi Rezaei ◽

Ali Ramazani ◽

Fahimeh Hokmabadi

Keyword(s):

Tenofovir Disoproxil Fumarate ◽

Dosage Form ◽

Potassium Dihydrogen Phosphate ◽

Hplc Method ◽

Assay Method ◽

Simultaneous Estimation ◽

Dihydrogen Phosphate ◽

Rp Hplc ◽

Successful Separation ◽

Tablet Dosage

Introduction: The purpose of this study is the development and validation of assay test for Tenofovir Disoproxil Fumarate (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in combined tablet dosage form by Reverse Phase (RP) HPLC. Materials and Methods: The assay method by HPLC was found to be linear in the concentration range of 15-150 µg/mL, 10-100 µg/mL and 30-300 µg/mL for TDF, FTC, and EFV, respectively. Successful separation of combined drugs was achieved by isocratic elution on a Phenomenex® C8 column (250 mm × 4.6 mm, 5µm). The mobile phase was composed of buffer pH: 7.0 ± 0.05 potassium dihydrogen phosphate, acetonitrile and methanol (40:40:20 v/v) at the flow rate of 1 mL/min using UV detection at 262 nm, column oven temperature 25ºC, and injection volume 20 µL. Results: The analytical results were validated by recovery studies. All the parameters of validation were in the acceptance range. This developed method was successfully applied for simultaneous estimation the amount of TDF, FTC and EFV in the bulk and marketed dosage forms.

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Development and validation of RP-HPLC and UV method for erlotinib hydrochloride tablets

IP International Journal of Comprehensive and Advanced Pharmacology ◽

10.18231/j.ijcaap.2021.026 ◽

2021 ◽

Vol 6 (3) ◽

pp. 144-151

Author(s):

R Vijay Amirtharaj ◽

S Lavanya

Keyword(s):

High Performance ◽

Potassium Dihydrogen Phosphate ◽

High Performance Liquid Chromatographic ◽

Hplc Method ◽

Dihydrogen Phosphate ◽

Uv Detector ◽

Column Temperature ◽

Development And Validation ◽

Tablet Dosage ◽

Liquid Chromatographic

A simple, sensitive, precise, selective reverse phase high performance liquid chromatographic method was developed and validated for erlotinib hydrochloride in tablet dosage form.(0.02M)The separation was achieved on C18 column (150mm×4.6mm.i.d.,5.0μm) using potassium dihydrogen phosphate: acetonitrile in the ratio 50:50v/v as mobile phase having pH 4.5 was adjusted with methanol and flow rate 1ml/min. Detection was carried out using a UV detector at 248nm. The column temperature was adjusted at 30ᵒC. The method was validated for precision, linearity and range, stability and robustness. The developed and validated method was successfully applied for the quantitative analysis of ERLONAT tablets. The total chromatographic analysis time per sample was about 7min with Erlotinib eluting at 6.547min.Validation studies demonstrated that this HPLC method is simple, specific, rapid, reliable and reproducible. The standard curves were linear over the concentration ranges, 88.32- 132.48μg/ml for erlotinib. The high recovery confirms the suitability of the proposed method for the determination of Erlotinib in ERLONAT tablets. The results of analysis have been validated according to ICH guideline requirements. The method can be applied for Erlotinib hydrochloride tablets.

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Estimation of Levetiracetam in Tablet Dosage Form by RP-HPLC

E-Journal of Chemistry ◽

10.1155/2008/965430 ◽

2008 ◽

Vol 5 (s2) ◽

pp. 1098-1102 ◽

Cited By ~ 4

Author(s):

N. Appala Raju ◽

J. Venkateswara Rao ◽

K. Vanitha Prakash ◽

K. Mukkanti ◽

K. Srinivasu

Keyword(s):

Dosage Form ◽

Limit Of Detection ◽

Potassium Dihydrogen Phosphate ◽

Hplc Method ◽

Detector Response ◽

Dihydrogen Phosphate ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Tablet Dosage

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of levetiracetam in tablet dosage form. A Sun Fire C18, 250 x 4.6 mm, 5 μm partical size, with mobile phase consisting of acetonitrile and 0.03 M potassium dihydrogen phosphate (pH adjusted to 3.0 with orthophosphoric acid) in the ratio of 15:85 v/v was used. The flow rate was 1 mL /min and the effluents were monitored at 210 nm. The retention time was 5.53 min. The detector response was linear in the concentration of 20-240 μg/mL. The respective linear regression equation being Y= 22119.684 x 6829.3428. The limit of detection and limit of quantification was 0.16 and 0.5 μg/mL respectively. The percentage assay of levetiracetam was 99.87%. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of levetiracetam in bulk drug and in its pharmaceutical dosage form.

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