Development and Validation of RP-HPLC Method for the Estimation of Sitagliptin Phosphate in Tablet Dosage Form

Recent study was conducted to develop and validate analytical methods for estimation of Risedronate sodium in pure and pharmaceutical dosage form using UV Spectroscopy and RP- HPLC method. The first method (Method A) based on the UV Spectroscopy using 0.1M Hcl as diluent lambda max was found at 261 nm. Linearity existed perceived in the concentration between 10-50 μg/ml (r 2 = 0.999) for the method. The method was validated pertaining to linearity, precision and accuracy studies, LOD and LOQ consistent with ICH guidelines. The second method (Method B), based on determination of Risedronate sodium tablet dosage form by RP-HPLC method. Chromatography separation was carried out on a C18 (150X4.6 mm x5 µ) SS Column using Methanol: Ammonium formate (85:15) as the mobile phase at a flow rate of 1.0 ml/min. The chromatographic analysis was carried out in the reflectance and absorbance mode at 254 nm and retention time of the drug was found to be 1.11 ml/min for standard and tablet. Linear responses of the drug were in the concentration range of 200-1000 µg/ml. The accuracy of the method was assessed by standard dilution method and found to be 98% to 102% .The results of the analysis were validated statistically prism software. The method established was found to be simple, precise, linear, accurate and sensitive. The developed method can be used for routine quality control analysis of Risedronate sodium in pure and pharmaceutical dosage form.

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A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PYRANTEL PAMOATE AND PRAZIQUANTEL IN BULK AND PHARMACEUTICAL DOSAGE FORM

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2019v11i5.30488 ◽

2019 ◽

pp. 62-67 ◽

Cited By ~ 1

Author(s):

Rajesh R. ◽

JITHU JERIN JAMES

Keyword(s):

High Performance ◽

Dosage Form ◽

Correlation Coefficients ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Pyrantel Pamoate ◽

Rp Hplc ◽

Ich Guidelines ◽

Tablet Dosage

Objective: To develop a simple, accurate and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and subsequently validate for the simultaneous estimation of praziquantel (PZQ) and pyrantel pamoate (PP) in the pharmaceutical dosage form. Methods: The chromatographic separation was achieved on Phenomenex Luna C18 column (250 mm × 4.6 mm, 5 μm) as stationary phase maintained at an ambient temperature with a mobile phase comprising of water: acetonitrile (20: 80) at a flow rate of 1.0 ml/min and UV detection at 220 nm. Results: The retention time of PZQ and PP was found to be 3.897 min and 1.697 min respectively. The method was validated in terms of specificity, accuracy, precision, linearity and robustness as per ICH guidelines. Linearity was obtained in the concentration range of 20–60 μg/ml for both PZQ and PP with correlation coefficients of 0.987 and 0.998 respectively. The accuracy of the method was determined using a recovery test and found as 98.44 % to 100.35 %. All parameters are found to be within the acceptable limit. Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise for the simultaneous estimation of PZQ and PP in bulk and tablet dosage form.

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DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF EDOXABAN TOSYLATE IN TABLET DOSAGE FORMS

INDIAN DRUGS ◽

10.53879/id.57.07.11389 ◽

2020 ◽

Vol 57 (07) ◽

pp. 47-51

Author(s):

B. Anupama ◽

P. Tejaswi ◽

KNV. Chenchu Lakshmi ◽

A. Vishwanadh

Keyword(s):

High Performance ◽

Reversed Phase ◽

Dosage Forms ◽

Hplc Method ◽

Control Analysis ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Tablet Dosage ◽

Isocratic Mode

A rapid, simple and precise reversed phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of edoxabantosylate in tablets. The quantification was carried out using a Phenomenex C-18 column (250×4.6 mm i.d., 5µm particle size) in isocratic mode with mobile phase comprising of ammonium acetate buffer andacetonitrile in the ratio of 50:50 (V/V) at a flow rate 1 mL/min. The eluent was monitored at 240 nm. The retention time of the drug was 3.486 min. The calibration curve was linear in the concentration range of 5-25 µg/mL and per cent recovery ranged from 98.25-101.6.The developed method was validated as per ICH guidelines and the results obtained were satisfactory.The method can be applied for routine quality control analysis of edoxabantosylate in tablet dosage forms.

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DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE ESTIMATION OFTRANDOLAPRIL AND VERAPAMIL IN COMBINED TABLET DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.49.05.p0061 ◽

2012 ◽

Vol 49 (05) ◽

pp. 61-64

Author(s):

A. L Rao ◽

◽

R. V Bhaskara

Keyword(s):

High Performance ◽

Dosage Form ◽

High Performance Liquid Chromatographic ◽

Hplc Method ◽

Rp Hplc ◽

Ich Guidelines ◽

Liquid Chromatographic Method ◽

Development And Validation ◽

Tablet Dosage ◽

Liquid Chromatographic

A reverse phase high performance liquid chromatographic method was developed and validated asper ICH guidelines for estimation of trandolapril and verapamil in combined tablet dosage form. Theseparation was obtained using a mobile phase consisting of acetonitrile and phosphate buffer adjustingpH to 3.0 in the ratio of 70:30 v/v and using Waters C18 (250 x 4.6 mm, 5 mcm) column maintained atambient temperature. The flow rate was 1.2 mL min-1 and UV detection was monitored at 215 nm. Theretention time (min) and linearity range (mcg mL-1) for trandolapril and verapamil were (5.12, 2.70) and(20-60, 20-60), respectively. The method validation results are within the acceptance criteria for precision,accuracy and linearity. The proposed method was found to be suitable for routine quality control ofmarketed formulation containing these APIs.

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Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

10.33974/ijrpst/ ◽

2018 ◽

Vol 1 (1) ◽

pp. 12-21

Keyword(s):

Flow Rate ◽

Dosage Form ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Isocratic Mode

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

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Development and validation of new analytical method for the simultaneous estimation of amitriptyline and perphenazine in bulk and pharmaceutical dosage form by RP-HPLC

International Journal of Research in Pharmaceutical Sciences and Technology ◽

10.33974/ijrpst.v1i1.19 ◽

2018 ◽

Vol 1 (1) ◽

pp. 12-21

Author(s):

V Pavan Kumar ◽

B Ramadevi ◽

Shaik Karishma ◽

P Divya ◽

B Sivagami ◽

...

Keyword(s):

Flow Rate ◽

Dosage Form ◽

Pharmaceutical Formulations ◽

Hplc Method ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Ich Guidelines ◽

Development And Validation ◽

Isocratic Mode

A new, simple, precise, accurate and reproducible RP-HPLC method for simultaneous estimation of Amitriptyline and Perphenazine in bulk and pharmaceutical formulations was developed. Separation of Amitriptyline and Perphenazine was successfully achieved on Inertsil ODS (250x4.6mm) 5µm column in an isocratic mode utilizing Methanol: ACN: Water (50:30:20) at a flow rate of 1.0 ml/min and eluents were monitored at 253nm with a retention time of 2.440 and 5.503 minutes for Amitriptyline and Perphenazine respectively. The method was validated and it was found to be linear. The values of the correlation coefficient were found to 0.992 for Amitriptyline and 0.9992 for Perphenazine respectively. The LOD for Perphenazine and Amitriptyline were found to be and 33.8µg/ml and 4.2 µg/ml. The LOQ for Perphenazine and Amitriptyline were found to be 20.88µg/ml and 12.12µg/ml respectively. The percentage recoveries for Amitriptyline and Perphenazine were found to be within the limit indicates that the proposed method is highly accurate. The method was extensively validated according to ICH guidelines.

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A Validated Stability Indicating RP-HPLC Method for the Estimation of an Anti-Cancer Drug Regorafenib in Pure and Pharmaceutical Dosage Form

JOURNAL OF PHARMACEUTICAL CHEMISTRY ◽

10.14805/jphchem.2017.art70 ◽

2017 ◽

Vol 4 (1) ◽

pp. 5-10 ◽

Cited By ~ 1

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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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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Method Development and Validation of RP-HPLC Method for the Estimation of Ormeloxifene

International Journal of Applied Pharmaceutical Sciences and Research ◽

10.21477/ijapsr.v2i03.8253 ◽

2017 ◽

Vol 2 (03) ◽

pp. 78-82

Author(s):

Anusha Shivaraj ◽

Shireesha Battula

Keyword(s):

Mobile Phase ◽

Room Temperature ◽

Method Development ◽

Hplc Method ◽

Rp Hplc ◽

Ich Guidelines ◽

Method Development And Validation ◽

Development And Validation ◽

Isocratic Mode ◽

Ich Guideline

A new simple, specific, accurate, precise RP-HPLC method has been developed for the estimation of Ormeloxifene. The chromatographic separation for Ormeloxifene was achieved with mobile phase containing methanol :ACN(70:30 v/v), agilent C18 column (4.6 x150 mm) 5 μ at room temperature and UV detection at 274nm.The compounds were eluted in the isocratic mode at a flow rate of 1ml/min. The retention time of Ormeloxifene was found to be 2.497min. The method was validated according to ICH guideline for linearity, specificity, precision, accuracy, LOD, LOQ and robustness in accordance with ICH guidelines.

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Method Development and Validation for Estimation of Istradefylline in Tablet Dosage form by RP-HPLC

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.00829 ◽

2021 ◽

pp. 4767-4772

Author(s):

Krishna Kishore Adireddy ◽

Srinivasa Rao Baratam ◽

Nagarjuna Hari Pratap S

Keyword(s):

Dosage Form ◽

Method Development ◽

Hplc Method ◽

Solution Stability ◽

Rp Hplc ◽

Ich Guidelines ◽

Method Development And Validation ◽

Development And Validation ◽

Tablet Dosage

A simple, rapid, accurate and precise RP-HPLC method was developed and validated for the determination of Istradefylline in table dosage form. Chromatographic analysis of the drug was achieved on Shimadzu HPLC comprising of LC- 20 AD binary gradient pump, a variable wavelength programmable SPD-20A detector and SCL system controller. C18G column (250 mm x 4.6 mm, 5 μ) as stationary phase with mobile phase consisting of 0.1 % orthophosphoric acid and acetonitrile in the ratio of 30: 70 v/v. The method showed a good linear response in the concentration range of 10-90 μg/ml with correlation coefficient of 0.9993. The flow rate was maintained at 1.0 ml/min and detection was carried out at 246 nm. The retention time was 3.125 min. The method was statistically validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and sensitivity. The results obtained in the study were within the limits of ICH guidelines and hence this method can be used for the determination of istradefylline in tablet formulation.

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