Method development and validation of RP-HPLC method for the determination of sumatriptan in bulk and pharmaceutical dosage form

2021 ◽  
pp. 5856-5862
Author(s):  
Rakam Gopi Krishna ◽  
M. Srinivasa Murthy ◽  
V. Kavya
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Solvent System ◽  
Hplc Method ◽  
Forced Degradation ◽  
Pharmaceutical Dosage Form ◽  
Drug Products ◽  
Rp Hplc ◽  
The Stability

The objective of the study was to develop RP-HPLC method for the determination of purity of sumatriptan in bulk and pharmaceutical dosage form. The development of an analytical method for the determination of drugs by HPLC has received considerable attention in recent years because of their importance in quality control of drugs and drug products. The aim of this current study was to develop a simple, rapid, precise, accurate and sensitive HPLC method for the analysis of sumatriptan in bulk and its pharmaceutical dosage form by using solvent system of TEA : ACN : methanol in the ratio 80:10:10 and C8 ODS Inertsil (250*4.6mm, 5i.d) stationary phase. The chromatographic condition is set at flow rate of 1ml/min with PDA detector at 221 nm. As per ICH requirements validation studies are carried out by using freshly prepared solutions. The linearity was demonstrated over the concentration range of 5-150 µg / ml and value was found to be as 0.99998. The %RSD of precision was found to be 0.260. The LOD and LOQ were found to be 1.967μg/ml and 5.961μg/ml respectively. Forced degradation studies were carried out under various stress conditions to demonstrate the stability-indicating capability of the developed RP-HPLC method. The proposed method was found to be simple, precise, accurate and validated according to the International Council for Harmonisation guidelines.

New RP-HPLC Method Development and Validation for the Determination of Pazopanib Hydrochloride in Tablet Dosage Form

2017 ◽  
Vol 8 (1) ◽  
Author(s):  
Rajesh Babu Y. ◽  
Appala Raju N.
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug ◽  
The Stability

The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination of Pazopanib hydrochloride in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Pazopanib hydrochloride in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The % recovery values were found to be within the limits, which showed that the method was accurate. The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 2. The developed method was successfully applied for determination of Pazopanib hydrochloride in pharmaceutical dosage form. The results obtained are in good agreement with those obtained by using the standard method.

Simple and Sensitive Analytical Method Development and Validation of Nitazoxanide and Ofloxacin by RP- HPLC

2021 ◽  
pp. 84-86
Author(s):  
Abhishek Agrawal ◽  
Prem Kumar Bichala ◽  
Swapna Singh
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Laboratory ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Development And Validation

RP-HPLC method was developed for the determination for the validation of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. Chromatographic separation was performed on Develosil ODS HG-5 RP C18, 15x4.6mm, 5µm column, with mobile phase comprising of mixture of ACN: Methanol: Citric acid in the ratio of 50:45:5 v/v, at the flow rate 1.0ml/min and the detection was carried out at 296nm. The comprehensive forced stress testing has been carried out as per USP guidelines. The drug Nitazoxanide is subjected to synthetic Benzamide, and the drug Ofloxacin is subject to synthetic Fluoroquinolone. RP- HPLC method was developed to separate analyte from all other degradation peaks. The method was successfully validated as per ICH guidelines for the purpose of conducting studies of the analyte in quality control laboratory. The drug was subjected to different degradation conditions; it was found to be stable in all degradation conditions. The purposed HPLC method was found to be precise, specific, accurate, rapid and economical for the determination of Nitazoxanide and Ofloxacin in pharmaceutical dosage form. The sample recoveries in all formulations were in good agreement with their respective label claims and this method can be used for routine analysis. The linearity range was found to be 0-50 (µg/ml) for Nitazoxanide and 0-50 (µg/ml) for Ofloxacin. Calibration curve was plotted and correlation co-efficient for the drugs found to be 0.999 and 0.997. Hence the results obtained were within the limits.

scholarly journals Analytical Method Development and Validation and Forced Degradation Stability-Indicating Studies of Favipiravir by RP-HPLC and UV in Bulk and Pharmaceutical Dosage Form

2021 ◽  
pp. 254-271
Author(s):  
Sayyed Nazifa Sabir Ali ◽  
Lajporiya Mobina ◽  
Manjra Mehfuza ◽  
Patel Seema ◽  
Aejaz Ahmed ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Forced Degradation ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation

Aims: To develop and validate a new, simple, rapid, precise, and accurate An Eco-friendly RP-HPLC and UV-Method Development and Validation for an estimation of Favipiravir in Bulk and pharmaceutical dosage form followed by Forced Degradation Studies. Study Design: This was employed for UV-visible (200-400 nm and 400-800 nm respectively) and RP-HPLC method development using C 18 inertsil column and optimization of variables for Favipiravir estimation in bulk and formulations. Place and Duration of the Study: The present work was carried out at Ali-allana College of Pharmacy, Akkalkuwa between the duration of November-2020 to February-2021. Methodology: UV-Spectroscopic method was developed for the estimation of Favipiravir in the bulk and pharmaceutical dosage form. The solvent selected for the Favipiravir UV analysis was water, the solution in a range of 2-10µg/ml was scanned in the UV region from 200-400 nm and the λmax value was determined. The RP-HPLC method was developed on inertsil ODS-3V C18 150 mm x 4.6mm x 5μ column using buffer pH 3.5: acetonitrile [90:10] as mobile phase at flow rate 1.0 ml/min and PDA detection at 358 nm. Results: The maximum absorbance was observed at 358 nm. The wavelength 358 nm was selected for further analysis of Favipiravir. The calibration curve was determined using drug concentrations ranging from 2-10 µg/ml. The % recovery for accuracy was 100.50-100.76%. The method was to be precise with a % RSD value 0.51-1.37 and 0.77-1.78 for intraday and Interday respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0723 &0.219 µg/ml respectively by UV method. The RP-HPLC method was shown to be linear in the 50-250 μg/ml concentration range. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 2.186 & 6.626 μg/ml respectively. The method was to be precise with a % RSD value 0.25-1.53 and 0.86-1.68 for intraday and inter-day respectively. Conclusion: Here we conclude that the developed UV and RP-HPLC methods are precise, accurate, sensitive, and reproducible for the quantitative estimation of Favipiravir bulk and its formulation. The developed method can be used by the pharmaceutical industries for the routine analysis of Favipiravir, in particular by UV and RP-HPLC. The main features of the proposed method are economic and eco-friendly with less retention time around 5.0 min.

Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Imatinib Mesylate

2017 ◽  
Vol 8 (01) ◽  
Author(s):  
Y. Rajesh Babu ◽  
N. Appalaraju
Keyword(s):  
Imatinib Mesylate ◽  
Dosage Form ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug ◽  
The Stability

The aim of this paper was to develop and validate the stability indicating RP-HPLC method for the determination of Imatinib mesylate in bulk and pharmaceutical dosage forms. A simple, accurate, precise, sensitive and stability indicating RP-HPLC method has been developed for the determination of Imatinib mesylate in bulk drug and pharmaceutical dosage form, in which separations are done using develosil C18, 5μm, 150 × 4.6mm i.d. column at a flow rate of 1.0mL/min with an injection volume of 20μL. The beer’s law was obeyed over the concentration range of 5 - 35μg/mL. The correlation coefficient was found to be 0.996 and it showed good linearity, reproducibility, precision in this concentration range. The % recovery values were found to be within the limits, which showed that the method was accurate. The LOD and LOQ were calculated using statistical methods. The % RSD values were less than 2. The developed method was successfully applied for determination of Imatinib mesylate in pharmaceutical dosage form. The results obtained are in good agreement with those obtained by using the standard method.

scholarly journals RP-HPLC Method Development and Validation for Determination of Tigecycline in Bulk and Pharmaceutical Dosage form

2021 ◽  
pp. 273-282
Author(s):  
K. Bhavyasri ◽  
C. H. Mounika ◽  
Narmada Vallakeerthi ◽  
M. Sumakanth
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Method Development ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Good Precision ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Water Ph

Aims: To develop and validate a new, simple, rapid, precise and accurate Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for the quantitative determination of Tigecycline in bulk and pharmaceutical dosage form. Study Design: Place and Duration of the Study: RBVRR women's college of pharmacy, Barkatpura, Hyderabad, between june 2019 and july 2020. Methodology: The RP-HPLC method was developed on Sunsil C18 150 mm x 4.6mm x 5µ column using acetonitrile : water (pH maintained at 3.5 with acetic acid) [70:30] as mobile phase at flow rate 0.8 ml/min and UV detection at 250 nm. Results: Tigecycline exhibited linearity over the concentration range of 5-40 µg/mL (R2 > 0.999). The analytical method showed good precision with % RSD below 2. The method showed suitable accuracy and robustness. Conclusion: Validation of the developed method was done as per International Conference on Harmonization (ICH) Q2R1 guidelines.

scholarly journals Novel Method development and Validation of Bortezomib in Bulk and Pharmaceutical dosage form by RP- HPLC

2019 ◽  
Vol 9 (1) ◽  
pp. 17-21
Author(s):  
Pasupuleti Laxmi Prasanna ◽  
Pedapanga Sandhya ◽  
Pittala Geetha ◽  
Vallapatla M Anuhya
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Wave Length ◽  
Hplc Method ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Method Development And Validation ◽  
Development And Validation

A simple, rapid, precise and accurate RP-HPLC method was developed and validated for the determination of Bortezomib, in bulk and pharmaceutical dosage form. The separation is achieved on RP-HPLC using a PDA detector by incorporation of enpower 2 software with a flow rate of 1.0ml/min using a mixture of Methanol and water (15:85% v/v) as mobile phase. The column used was Hypersil C18 (4.6×150mm, 5µ) at a wave length of 284nm. The retention time of the Bortezomib was 3.515min.. The linearity of the drug was 25-125µg/m and the method precision for the determination of assay was below 2.0% RSD. The proposed method was validated and applied for the estimation of Bortezomib in quality control of bulk and pharmaceutical dosage forms. Keywords: Bortezomib, RP-HPLC, validation.

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