scholarly journals Method Development and Validation of RP-HPLC method for Saxagliptin and Sitagliptin in Pharmaceutical Dosage Form - A Review

2021 ◽  
Vol 12 (2) ◽  
pp. 1338-1344
Author(s):  
Suma A.H. ◽  
Binoy Varghese Cheriyan ◽  
Vijey Aanandhi M. ◽  
Ramachandran S.
Keyword(s):  
Particle Size ◽  
Flow Rate ◽  
Phosphate Buffer ◽  
Dosage Form ◽  
Method Development ◽  
Uv Spectroscopy ◽  
Hplc Method ◽  
Uv Detection ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

The study's goal was to develop a plain, quick, and responsive RP-HPLC method for determining the concentrations of Saxagliptin and Sitagliptin in pharmaceutical bulk dosage form (bulk powders). Isocratic elution with Cosmosil C18 (250nm 4.6nm, 5m particle size) and UV detection at 212nm for Saxagliptin and Develosil ODS HG-5 RP-C18 (15cm 4.6mm, 5m particle size) and UV detection at 255nm for Sitagliptin were used in this chromatographic process. Methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: methanol and water (70:30) in a mobile solution with a flow rate of 0.8ml/min for Saxagliptin and (0.05m) phosphate buffer: These protocols have been put through their paces in accordance with ICH guidelines. The normal curves for Saxagliptin and Sitagliptin were observed to have a linear relationship across the analytical ranges of 10-50 g/ml and 30-70 g/ml, respectively. The accuracy, precision, limit of identification, the limit of quantification, and robustness of the system were all calculated. Various analytical methods such as UPLC (Ultra performance liquid chromatography), UV spectroscopy, LC-UV methods have performed to the quantitative determination of Saxagliptin and Sitagliptin drugs.

SIMULTANEOUS DETERMINATION OF PARACETAMOL, ACECLOFENAC AND TRAMADOL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (01) ◽  
pp. 35-40
Author(s):  
Rajesh Sharma ◽  
◽  
Mukesh C. Sharma ◽  
Gaurav Vijaywargiya
Keyword(s):  
Flow Rate ◽  
Chromatographic Separation ◽  
Phosphate Buffer ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Tramadol Hydrochloride ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc

Chromatographic separation of paracetamol, aceclofenac and tramadol hydrochloride was performed on a Chromatopak C-18 column (25 cm x 4.6mm i.d. x 5µm) as stationary phase with a mobile phase composed of phosphate buffer pH 7.0: acetonitrile (65:35 V/V), pH 7.0 (adjusted with triethylamine) at flow rate of 1mL/min. Detection was carried out at 265 nm. The retention times of paracetamol, aceclofenac and Tramadol hydrochloride were found to be 2.7, 4.5 and 6.0 min, respectively. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The method was found to be accurate, precise, specific, robust, and linear for the determination of paracetamol, aceclofenac and tramadol hydrochloride in pharmaceutical dosage form.

scholarly journals Simultaneous estimation of gabapentin and methylcobalamin in bulk and pharmaceutical dosage form by RP-HPLC

2019 ◽  
Vol 9 (1) ◽  
pp. 170-174
Author(s):  
Anjali Bakshi ◽  
K Monika ◽  
Shweta Bhutada ◽  
M. Bhagvan Raju
Keyword(s):  
Particle Size ◽  
Flow Rate ◽  
Retention Time ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the simultaneous estimation of Gabapentin & Methylcobalamin from bulk and formulation. Chromatographic separation was achieved Isocratically on an Inertsil C18 column (150x4.6, 5µ particle size) using a mobile phase Buffer: Acetonitrile in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, effluents were detected at 264 nm and 10µl of sample was injected. Retention time of Gabapentin & Methylcobalamin was found to be 2.7 and 4.13 min respectively. Linearity of the method was in the concentration range of 25-150 µg for Gabapentin & 0.125-0.750 µg for Methylcobalamin. Percent recoveries obtained for both the drugs were 100.00%. The percentage RSD for precision of the method was found to be less than 2%. The method was validated according to the ICH guidelines. The method developed was successfully applied for the analysis of simultaneous estimation of Gabapentin & Methylcobalamin tablets and was fairly good in comparison with other methods. Keywords: Gabapentin, Methylcobalamin, HPLC.

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

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.

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

2018 ◽  
Vol 11 (9) ◽  
pp. 431 ◽  
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.

Development and validation of RP-HPLC/UV methods for the estimation of Risedronate sodium in pure and pharmaceutical dosage form

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Ananda Thangadurai Subramaniam ◽  
Devi Velmurugan ◽  
Sambathkumar Ramanathan ◽  
Kamalakannan Dhanabalan ◽  
Jambulingam Munusamy ◽  
...  
Keyword(s):  
Dosage Form ◽  
Uv Spectroscopy ◽  
Hplc Method ◽  
Dilution Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

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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