RP-HPLC Method Development and Validation for the Estimation of Midostaurin in Bulk and Pharmaceutical Dosage Form

An elementary, Valid, speedy and decisive strategy was developed to determine Midostaurin quantitatively in a fixed dosage form. Effective Chromatographic separation of Midostaurin was achieved by using Hypersil C18 Column (250 mm X 4.6 mm internal diameter, five μm particle size) using a mobile phase composed of Methanol and Buffer in the proportion of 75:25(by volume). The Mobile phase was siphoned using a gradient HPLC system at a flow rate of 1.0 ml/min, and quantification was based on peak area measurement at 270 nm. RT (Retention Time) for Midostaurin was 2.142 min, and dimensionality of Midostaurin was found to be linear with a statistic value of 0.999. The acceptance criteria of precision were relative variance should be less than 2.0%, and also the strategy showed precision 0.3 for Midostaurin, which shows that the tactic was precise. The full Recovery was found to be 99.96 %. Detection Limit and Quantitation Limit values for Midostaurin were found as 0.439 & 1.466. The exactness and authenticity were assessed by evaluation of validation parameters like linearity, precision, specificity, accuracy, LOD, LOQ values as per ICH guidelines. The proposed strategy has been applied to the formulation without additives interference and specific for the estimation of Midostaurin.

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NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN AND NEBIVOLOL HCL IN PHARMACEUTICAL DOSAGE FORM

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i9.27016 ◽

2018 ◽

Vol 11 (9) ◽

pp. 431 ◽

Cited By ~ 1

Author(s):

Heena Ar Shaikh ◽

Vandana Jain

Keyword(s):

High Performance ◽

Dosage Form ◽

Method Development ◽

Limit Of Detection ◽

Hplc Method ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Validation Parameters ◽

Hplc Method Development

Objective: A simple, accurate, precise, robust reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of telmisartan and nebivolol hydrochloride (HCl) simultaneously in its combined dosage form.Methods: The compounds were well resolved in an isocratic method using the mobile phase composition of acetonitrile: Buffer (potassium dihydrogen orthophosphate pH adjusted 3.1 with orthophosphoric acid) in a ratio of 40:60 v/v at a flow rate of 1.2 ml/min using C18 Shim-pack (150 mm × 4.6 mm, 5 μ) column. The detection was carried out at 280 nm.Results: The retention time of telmisartan and nebivolol HCl was 4.8 min and 6.5 min, respectively. The developed method was validated by evaluating various validation parameters such as linearity, precision, accuracy, robustness, specificity, limit of detection, and limit of quantification according to the international council for harmonization guidelines. The standard calibration curve was obtained in the concentration range of 24–56 μg/ml for telmisartan and 3–7 μg/ml for nebivolol HCl. The overall average % recovery was found out to be 100.35 for telmisartan and 98.84 for nebivolol HCl.Conclusion: Statistical analysis of the data showed that the method is reproducible and selective for the estimation of telmisartan and nebivolol HCl. The proposed method could be used for analysis of telmisartan and nebivolol HCl in their dosage form.

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Stability indicating RP-HPLC method development and validation for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and pharmaceutical dosage form

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v10i3.1381 ◽

2019 ◽

Vol 10 (3) ◽

pp. 1841-1846

Author(s):

Narayanaswamy Harikrishnan ◽

Vijaya vara Prasad M ◽

Gejalakshmi Subramanian ◽

Babu S

Keyword(s):

Dosage Form ◽

Method Development ◽

Hplc Method ◽

Simultaneous Estimation ◽

Control Analysis ◽

Total Recovery ◽

Pharmaceutical Dosage Form ◽

Validation Parameters ◽

Hplc Method Development ◽

Development And Validation

A plain sailing, unambiguous, speedy and error-free methodology was progressed for the quantifiable concurrent estimation of Pibrentasvir and Glecaprevir in conglomerated pharmaceutical dosage form. The contrivance was based on Chromatographic separation of both the drugs in reverse phase mode using C18 (250 X 4.6 mm), 5μ by utilizing phosphate buffer (pH 4.0) and Methyl alcohol in the ratio of 30:70 v/v was allowed to flow through column at a rate of 1.0 ml/min, and the detection wavelength was set at 251 nm. The time of retention was found to be 2.205 min for Glecaprevir and 4.996 min for Pibrentasvir. The dimensionality of Glecaprevir and Pibrentasvir was in linear range with a parametric statistic of 0.999 and 0.999. The acceptance criteria of precision was RSD should be not more than 2.0%, and the method showed precision 0.6 and 0.5 for Glecaprevir and Pibrentasvir, which shows that the method was precise. % Assay was found as 100.83 and 100.23, which show that the method was useful for routine analysis. The total recovery was founded to be100.40% and 100.25% for Glecaprevir and Pibrentasvir. LOD and LOQ for Glecaprevirwas found as 2.98 and 10.00 and LOD and LOQ for Pibrentasvir was found as 3.00 and 9.98. The methodology was assessed by various validation parameters in accordance with ICH Guidelines which indicates the method can be employed for routine quality control analysis.

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RP-HPLC Method Development and Validation for the Estimation of Sacubitril and Valsartan in Pharmaceutical Dosage Form

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.01008 ◽

2021 ◽

pp. 5797-5802

Author(s):

G.M. Kadam ◽

A.L. Puyad ◽

T.M. Kalyankar

Keyword(s):

Dosage Form ◽

Method Development ◽

Limit Of Detection ◽

Hplc Method ◽

Content Uniformity ◽

Phase Detection ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Hplc Method Development

A new, economical, simple, accurate, and precise RP-HPLC method was developed for simultaneous assay and content uniformity determination of Sacubitril and Valsartan in bulk and pharmaceutical dosage form. The separation of Sacubitril and Valsartan was achieved within 6 minutes on Phenomenex Luna C18 250 mm x 4.6mm and 5µm Particle Size, column using Acetonitrile: Methanol: Water (30:55:15% v/v/v) as the mobile phase. Detection was carried out at 250 nm wavelength. The retention time of Sacubitril and Valsartan was found to be 2.361 and 3.304 min, respectively. The validation of the developed method was performed in terms of specificity, accuracy, precision, linearity, the limit of detection, the limit of quantification as mentioned in International Conference on Harmonization (ICH) guidelines. The method showed adequate sensitivity concerning linearity, accuracy, and precision over the range 12-36 μg/ml and 13-39 μg/ml for Sacubitril and Valsartan, respectively. The percentage recoveries obtained for Sacubitril and Valsartan were found to be in the range of 98.00 – 102.00 %. The proposed method is suitable for use in quality-control laboratories for quantitative analysis.

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HPLC METHOD DEVELOPMENT, VALIDATION, AND FORCED DEGRADATION FOR SIMULTANEOUS ANALYSIS OF OXYCODONE AND NALTREXONEIN PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.56.02.11163 ◽

2019 ◽

Vol 56 (02) ◽

pp. 31-38

Author(s):

R. S. Ch Phani ◽

◽

K. R. S. Prasad ◽

R. M Useni

Keyword(s):

Dosage Form ◽

Method Development ◽

Hplc Method ◽

Forced Degradation ◽

Solution Stability ◽

Pharmaceutical Dosage Form ◽

Column Temperature ◽

Degradation Study ◽

Ich Guidelines ◽

Hplc Method Development

A simple, precise and stability-indicating RP-HPLC method was developed for simultaneous quantification of oxycodone (OXCD) and naltrexone (NTRX) in combined dosage form. The developed method was validated with respect to precision, linearity, accuracy, robustness, ruggedness, sensitivity and solution stability. The method was developed with ammonium di hydrogen phosphate buffer (pH 5.0) and acetonitrile in a ratio of 55:45 (v/v) as mobile phase at a flow rate of 1.0 mL/minute over Intersil ODS C18 column (250 mm × 4.6 mm×5μ).The UV detection wavelength was fixed at 235 nm. The column temperature was maintained at ambient temperature. The method showed good linearity with correlation coefficient values of 0.9990 and 0.9994 for OXCD and NTRX. The percent recoveries of the two drugs found within the limits of 98.0–102.0%. The LOQ concentrations of OXCD and NTRX are 0.625 μg/ mL and 0.075 μg/mL, respectively. The LOD concentrations of OXCD and NTRX are 0.3125 μg/mL and 0.0375 μg/mL, respectively. According to ICH guidelines forced degradation study was validated.

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