DEVELOPMENT AND VALIDATION OF RP-HPL C METHOD FOR THE ESTIMATION OF ASCORBIC ACID IN HEALTH DRINKS

INDIAN DRUGS ◽  
2016 ◽  
Vol 53 (10) ◽  
pp. 43-47
Author(s):  
N. Mallikarjuna Rao ◽  
◽  
D. Gowri Sankar
Keyword(s):  
Particle Size ◽  
Ascorbic Acid ◽  
Acetic Acid ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Development And Validation

A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of ascorbic acid in health drinks. Isocratic elution at a flow rate of 0.9mL/min was employed on a symmetry C18 column (250x4.6mm, 0.5μ in particle size) at ambient temperature. The mobile phase consisted of water with acetic acid: methanol 95:5% (V/V). The UV detection wavelength was 245 nm and 20μL sample was injected. The retention time for ascorbic acid was 4.61± 0.22 min. The percentage RSD for precision and accuracy of the method was found to be less than the method which was validated as per the ICH guidelines. The method was successfully applied for routine analysis of ascorbic acid in health drinks.

scholarly journals Validated RP-HPLC Method for the Determination of Buspirone in Pharmaceutical Formulations

2011 ◽  
Vol 2011 ◽  
pp. 1-3 ◽  
Author(s):  
M. V. Basaveswara Rao ◽  
A. V. D. Nagendrakumar ◽  
Sushanta Maiti ◽  
Guttikonda Raja
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Precision And Accuracy ◽  
Tablet Dosage

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for the rapid assay of the Buspirone in tablet dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on a symmetry C18 (250×4.6 mm, 5 μm in particle size) at ambient temperature. The mobile phase consisted of water : acetonitrile : methanol 45 : 35 : 20(V/V). The UV detection wavelength was 210 nm, and 20 μL sample was injected. The retention time for the Buspirone was 7.057 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method can be successfully applied for the routine analysis of Buspirone in tablet dosage form.

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

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.

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

2010 ◽  
Vol 3 (2) ◽  
pp. 978-986
Author(s):  
Wamorkar V V ◽  
C S Ramaa ◽  
Manjunath S Y ◽  
V Malla Reddy
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Good Resolution ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Different Levels

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

scholarly journals A Validated RP-HPLC Method for Simultaneous Estimation of Atenolol and Indapamide in Pharmaceutical Formulations

2011 ◽  
Vol 8 (3) ◽  
pp. 1238-1245 ◽  
Author(s):  
G. Tulja Rani ◽  
D. Gowri Sankar ◽  
P. Kadgapathi ◽  
B. Satyanarayana
Keyword(s):  
Particle Size ◽  
Mobile Phase ◽  
Dosage Form ◽  
Orthophosphoric Acid ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of atenolol and indapamide from bulk and formulations. Chromatographic separation was achieved isocratically on a Waters C18 column (250×4.6 mm, 5 µ particle size) using a mobile phase, methanol and water (adjusted to pH 2.7 with 1% orthophosphoric acid) in the ratio of 80:20. The flow rate was 1 mL/min and effluent was detected at 230 nm. The retention time of atenolol and indapamide were 1.766 min and 3.407 min. respectively. Linearity was observed in the concentration range of 12.5-150 µg/mL for atenolol and 0.625-7.5 µg/mL for indapamide. Percent recoveries obtained for both the drugs were 99.74-100.06% and 98.65-99.98% respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of atenolol and indapamide from their combined dosage form.

scholarly journals Development and Validation of RP-HPLC method for Simultaneous Estimation of Metformin and Pioglitazone

2017 ◽  
Vol 5 (01) ◽  
pp. 48-50
Author(s):  
Uttam Kumar Agrawal ◽  
Jeyabalan Govindasamy
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Drug Form ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation

A new simple, accurate ,precise and reproducible RP-HPLC method has been developed for simultaneous estimation of metformin and pioglitazone in bulk drug form using proper HPLC system. The mobile phase consists of phosphate buffer and acetonitrile in the ratio of 35:65 at pH 3.4.The detection wavelength was carried out at 228 nm. The method was linear over the concentration range for metformin 50-100 μg/mL and for pioglitazone 20-180 μg/mL. The recoveries of metformin and pioglitazone were found to be 100.5 and 98.7% respectively. The validation of method was carried out utilizing ICH-guidelines. The described HPLC method method was successfully for the analysis of pharmaceutical formulations containing dosage form.

scholarly journals A New Quantitative Analytical Method Development and Validation for the Analysis of Boceprevir in Bulk and Marketed Formulation

2018 ◽  
Vol 10 (03) ◽  
Author(s):  
Bhetanabotla Chandramowli ◽  
B.M Syam Kumar ◽  
D.V. R. N. Bhikshapathi ◽  
Bigala B Rajkamal
Keyword(s):  
Chromatographic Analysis ◽  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Capsule Formulation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Method Development And Validation ◽  
Development And Validation

A simple, precise and accurate RP-HPLC technique was developed and the developed method was validated for the regular analysis of Boceprevir. Chromatographic analysis was performed by selecting X-Terra ODS ( C18) column (4.6 mm i.d. × 250 mm, 5μ), Acetonitrile : Phosphate buffer pH -3 ( 90 : 10% v/v) as mobile phase, 1.0 ml/min as flow rate and 20μl injection volume. The LC chromatographic peak was eluted at 3.6 min at 235 nm as UV detection wavelength. The developed method was validated as per the ICH guidelines and the Validation parameters were specificity, accuracy, linearity, precision, LOD and LOQ. Linear relationship for Boceprevir established in the concentration range of 50 to 150μg/mL. Accuracy in terms of percentage recovery found in the range between 98 to 101%. LOD and LOQ values were found to be 2.3 and 7.123μg/mL respectively. The results of the method established that the new RP-HPLC method is convenient and simple in regular analysis of Boceprevir in bulk and capsule formulation.

scholarly journals SIMULTANEOUS DETERMINATION OF TIGECYCLINE AND ITS POTENTIAL IMPURITIES BY A STABILITY-INDICATING RP-HPLC-UV DETECTION TECHNIQUE

2022 ◽  
pp. 75-82
Author(s):  
V. N. V. KISHORE ◽  
G. V. RAMANA
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Buffer Mixture ◽  
Bulk Drug ◽  
Tablet Dosage

Objective: Stability representing the RP-HPLC method was established for synchronized quantification of Tigecycline and its impurities. This method was confirmed for its applicability to both tablet dosage and bulk drug forms. Methods: Intended for an isocratic elution, a mobile phase containing methanol: 10 mmol Triethylamine Buffer mixture (75:25 v/v, pH 6.1) was used at 1 ml/min flow rate and Agilent ZORBAX Eclipse XDB C18 (250 mm × 4.6 mm, 5 μm) column. Results: At 231 nm as wavelength, high-pitched peaks of Tigecycline (Tig) and its impurities (1and2) were detected at 6.55, 8.73 and 4.87 min correspondingly. The linearity of tigecycline and its impurities (impurity-1 and 2 and) were estimated with ranging from 75–450 µg/ml for Tigecycline and 1–6 µg/ml for both impurity 1 and 2. The corresponding recognition limits (LOD and LOQ) of the tigecycline and its impurities were originated to be (1.37,0.047 and 0.071 µg/ml) and (4.15, 0.143 and 0.126 µg/ml). Conclusion: The technique was effectively stretched for stability signifying studies under different stress conditions. Justification of the method was done as per the current ICH guidelines.

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.

Method Development and Validation for Estimation of related Substances in Tilorone Dihydrochloride using RP¬-HPLC

2021 ◽  
pp. 3319-3324
Author(s):  
M. Zeba Baktiyar ◽  
B. Mohammed Ishaq ◽  
Siva Sanker Reddy L ◽  
Sreenivasulu M.
Keyword(s):  
Mobile Phase ◽  
Method Development ◽  
Hplc Method ◽  
Column Temperature ◽  
Related Substances ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Wide Range ◽  
Method Development And Validation ◽  
Development And Validation

A simple, precise and reproducible RP-HPLC method was developed for the estimation of related substances in tilorone dihydrochloride. Quantification was performed using a Zorbax SB-phenyl column (150 × 4.6mm, 5µ) with mobile phase A: 20mM potassium dihydro phosphate + 2ml of triethylamine, pH 2.30 and mobile phase B: acetonitrile, methanol and water 60: 20: 20% v/v. A gradient program was followed with a run time of 55 minutes at a flow rate of 1.0 ml/min. The column temperature was maintained at 40°C, the injection volume was 10 µl and the detection was performed at 269nm using a PDA detector. The retention time of Tilorone dihydrochloride was found to be 10.36 minutes. The proposed method has been validated according to the ICH guidelines for Linearity, Precision, Accuracy, LOD, and LOQ. The method was linear from 0.157 - 3.934μg/ml for standard, 0.153-3.820μg/ml and 0.166 - 4.140μg/ml for impurities, TLHC01 and TLHC02 respectively. The impurities TLHC01 and TLHC02 have been mapped in all stress conditions. The LOD and LOQ of TLHC01 were found at 1.757μg/ml and 5.857μg/ml and 1.919μg/ml and 6.396μg/ml respectively for TLHC02 respectively. Statistical analysis showed that the method was precision, reproducible, selective, specific and accurate for the analysis of Tilorone dihydrochloride and its impurities. The wide range of linearity, sensitivity, precision, short retention times and simple mobile phase have shown that the method is suitable for the routine quantification of mass impurities of tilorone hydrochloride and its dosage pharmaceutical forms with high precision and accuracy.

scholarly journals A Validated RP-HPLC Method for the Estimation of Pizotifen in Pharmaceutical Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
M. V. Basaveswara Rao ◽  
A. V. D Nagendrakumar ◽  
Sushanta Maiti ◽  
N. Chandrasekhar
Keyword(s):  
Flow Rate ◽  
Mobile Phase ◽  
Dosage Form ◽  
Hplc Method ◽  
Isocratic Elution ◽  
Pharmaceutical Dosage Form ◽  
Reliable Determination ◽  
Rp Hplc ◽  
Ich Guidelines

A simple, selective, linear, precise, and accurate RP-HPLC method was developed and validated for rapid assay of Pizotifen in pharmaceutical dosage form. Isocratic elution at a flow rate of 1.0 mL/min was employed on Chromosil C18 (250 mm × 4.6 mm, 5 μm) column at ambient temperature. The mobile phase consists of methanol : acetonitrile in the ratio of 10 : 90 v/v. The UV detection wavelength was 230 nm, and 20 μL sample was injected. The retention time for Pizotifen was 2.019 min. The percent RSD for accuracy of the method was found to be 0.2603%. The method was validated as per the ICH guidelines. The method can be successfully applied for routine analysis of Pizotifen in the rapid and reliable determination of Pizotifen in pharmaceutical dosage form.

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