scholarly journals Spectrophotometric Method Development and Validation for Simultaneous Estimation of Nebivolol hydrochloride and Valsartan in Bulk and Combined Pharmaceutical Dosage Form in Release Media

2019 ◽  
Vol 11 (06) ◽  
Author(s):  
Chandani Makvana ◽  
Satyajit Sahoo
Keyword(s):  
Spectrophotometric Method ◽  
Phosphate Buffer ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Limit Of Quantitation ◽  
Nebivolol Hydrochloride ◽  
Tablet Dosage

A simple, rapid, precise, accurate and sensitive spectrophotometric method has been developed for the simultaneous estimation and validation of Nebivolol Hydrochloride (NEB) and Valsartan (VAL) in pure and combined tablet dosage forms. Pure drug samples of NEB and VAL were dissolved in 67 mM Phosphate buffer pH 6.8 with 0.5% sodium dodecyl sulphate (SDS) and found to have absorbance maxima at 280 nm for NEB and 250 nm for VAL, respectively. The linearity lies between 10-70μg/ml for NEB and 10-60μg/ml for VAL in this method. The correlation coefficient (r2) was found to be 0.9965 for NEB and 0.9960 for VAL. The % recoveries obtained were 95.65%-109.85% for NEB and 97.42%-101.43% for VAL. The % RSD found 0.271%-1.490% for intraday and 0.334%-1.917% for interday for NEB and 0.188%-0.944% for intraday and 0.392%-1.197% for interday for VAL. The limit of detection and limit of quantitation for NEB were found to be 4.608μg/ml and 13.965μg/ml respectively and the limit of detection and limit of quantitation for VAL were found to be 4.348μg/ml and 13.178μg/ml respectively. Simultaneous calibration of both drugs in 67 mM Phosphate buffer pH 6.8 with 0.5% SDS shows that λmax of one drug does not interfere on the λmax of other drug. Recovery study was performed to confirm the accuracy of the method. The results of analysis have been validated statistically by recovery studies as per International Conference on Harmonization guidelines. The method showed good reproducibility and recovery with % RSD Lessthan 2. Hence, this proposed method was found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of NEB and VAL in pure and combined tablet dosage form.

Analytical Method Development and Validation for Simultaneous Estimation of Trimetazidine Hydrochloride and Metoprolol Succinate Using HPTLC

2019 ◽  
Vol 15 (3) ◽  
pp. 243-250 ◽  
Author(s):  
Surendra Agrawal ◽  
Pravina Gurjar ◽  
Bhavik Katheriya
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Simultaneous Estimation ◽  
Metoprolol Succinate ◽  
Limit Of Quantitation ◽  
Label Claim ◽  
Tablet Dosage ◽  
Hptlc Method

Introduction: Trimetazidine and Metoprolol combination is more effective in the treatment of cardiac disorders as compared to single drug therapy.Background: Materials and Methods: A rapid, simple, and sensitive HPTLC method was developed for the simultaneous determination of Trimetazidine and metoprolol from its tablet dosage form and validated. In HPTLC method, standard and sample solutions of Trimetazidine hydrochloride and metoprolol succinate were applied on pre-coated silica gel G 60 F254 TLC plate, and developed by using mobile phase, n-butanol :water: methanol: ammonia as solvent (8.5:0.1:0.1: 0.85, v/v). The drugs on plate were scanned at 213 nm. The method produced compact and well-resolved bands at Rf of 0.32 ± 0.02 and 0.66 ± 0.02 for Trimetazidine Hydrochloride and Metoprolol succinate respectively. The range for linearity was observed as 500-2500 ng band-1 for Trimetazidine hydrochloride and 500-2500 ng band-1 for metoprolol succinate and correlation coefficient were 0.9991 and 0.9997 respectively. Conclusion: The developed method was validated according to the ICH guidelines for precision, accuracy, Limit of detection, Limit of quantitation, specificity and robustness. The method was checked for suitability in determination of Trimetazidine hydrochloride and Metoprolol succinate in their tablet dosage form. The assay result was found to be 99.64 % ± 0.45 and 99.94 % ± 0.53 of percentage label claim for Trimetazidine hydrochloride and Metoprolol succinate respectively.

Method Development and Validation of Spectrophotometric Methods for The Estimation of Rizatriptan Benzoate in Pure and Pharmaceutical Dosage Form

2021 ◽  
pp. 6003-6006
Author(s):  
Pushpa Latha E. ◽  
Sailaja B.
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Limit Of Quantification ◽  
Pharmaceutical Dosage Form ◽  
Rizatriptan Benzoate ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

Analytical UV derivative spectrophotometric method was developed and validated to quantify Rizatriptan Benzoate in pure drug and tablet dosage form. Based on the spectrophotometric characteristics of Rizatriptan Benzoate, a signal of zero (225nm), first (216nm), second (237nm), third (233nm), fourth (231nm) order derivative spectra were found to be adequate for quantification. The methods obeyed Beer's law in the concentration range of (0.1-360µg/ml) with square correlation coefficient (r2) of 0.999. The mean percentage recovery was found to be 100.01 ± 0.075. As per ICH guidelines the results of the analysis were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and were found to be satisfactory.

SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND INDAPAMIDE BY DUAL WAVELENGTH SPECTROPHOTOMETRIC METHOD FOR COMBINED PHARMACEUTICAL DOSAGE FORM

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (04) ◽  
pp. 50-54
Author(s):  
M. P Patel ◽  
◽  
M. R Patel ◽  
R Hasumati ◽  
M. N Noolvi ◽  
...  
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Dual Wavelength ◽  
Simultaneous Estimation ◽  
Uv Spectrophotometry ◽  
Amlodipine Besylate ◽  
Pharmaceutical Dosage Form ◽  
First Order ◽  
Absorbance Difference ◽  
Tablet Dosage

A simple, accurate, precise, rapid, economical UV spectrophotometry method, dual wavelength spectrophotometry, has been developed and validated for estimation of Indapamide (IND) and Amlodipine besylate (AML) in combined tablet dosage form and can be used in routine analysis. In this method, the absorbance at 360 nm and 256 nm of AML were same and no interference of IND at 360 nm. was observed. So, absorbance difference at 256-360 is used for estimation of IND and absorbance at 360 nm used for AML. The method was found to be linear in the concentration range of 3-18 μg/mL for IND (r2>0.99962) and 10-60 μg/mL for AML (r2>0.99969). Mean assay was found to be 99.32% and 101.34% for IND and AML respectively. In first order derivative spectrophotometry, the absorbance at 237.4 nm (ZCP of AML) and 241 nm (ZCP of IND) were used for estimation of IND and AML respectively. The method was found to be linear in the concentration range of 1.5-9 μg/mL for IND(r2=0.99983) and 5-30 μg/mL for AML(r2=0.99966). Mean assay was found to be 99.72% and 100.28% for IND and AML respectively.

scholarly journals Stability indicating RP-HPLC method development and validation for the simultaneous estimation of Grazoprevir and Elbasvir in bulk and pharmaceutical dosage form

2018 ◽  
Vol 1 (1) ◽  
pp. 1-7
Author(s):  
V. Pavan Kumar ◽  
A. Vijaya Kumar ◽  
B Sivagami ◽  
R. Charan Kumar ◽  
M. Niranjan Babu
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Simultaneous Estimation ◽  
Regression Equations ◽  
Pharmaceutical Dosage Form ◽  
Potassium Hydrogen ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

A simple, Accurate and precise method was developed for the simultaneous estimation of the Grazoprevir and Elbasvir in Tablet dosage form. Chromatogram was run through Kromosil C18 (250 x 4.6 mm), 5m. Mobile phase containing Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. Buffer used in this method was Di Potassium Hydrogen ortho Phosphate. Temperature was maintained at 30°C. Optimized wavelength selected was 215 nm. Retention time of Elbasvir and Grazoprevir and were found to be 2.503 min and 3.004. %RSD of the Elbasvir and Grazoprevir were and found to be 0.3 and 0.4 respectively. %Recovery was obtained as 98.17% and 99.83% for Grazoprevir and Elbasvir respectively. LOD, LOQ values obtained from regression equations of Grazoprevir and Elbasvir were 0.24, 0.73 and 0.06, 0.19 respectively. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TENELIGLIPTINE HYDROBROMIDE HYDRATE (TEN) AND METFORMIN HYDROCHLORIDE (MET) IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2019 ◽  
Vol 56 (08) ◽  
pp. 49-56
Author(s):  
H Joshi ◽  
A. Khristi ◽  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Assay Method ◽  
Metformin Hydrochloride ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Economic Method ◽  
Hplc Method Development ◽  
Tablet Dosage

A simple, accurate, precise, reproducible and economic method developed and validated for the simultaneous estimation of teneligliptine hydrobromide hydrate (TENE) and metformin hydrochloride (MET HCl) in pharmaceutical dosage form. TENE and MET HCl were estimated on Thermoscientific C18 column using mobile phase 0.01M PDP: methanol (45:55 % v/v) (pH 3.5 adjusted with 5% acetic acid) at flow rate 1.0 mL/min. Detection was carried out at 254 nm. The retention time of teneligliptine hydrobromide hydrate and metformin hydrochloride were 7.77 min and 2.64 min, respectively. The linearity was found to be 4-12 μg/mL and 100-300 μg/mL for TENE and MET HCl respectively. R2 value was found to be 0.998 and 0.995. For the assay method % recovery was found in the range of 98.16 – 101 for TENE and MET HCl. The LOD and LOQ were found to be 0.3527 and 1.0690 for TENE and 0.5077 and 1.538 for MET HCl respectively. Method was validated as per ICH guidelines.

Formulation, method development and validation of water soluble vitamins B1, B2 & B6 in bulk and tablet dosage form by HPTLC method

2018 ◽  
Vol 5 (1) ◽  
pp. 1-4
Author(s):  
Devi Velmurugan ◽  
Jambulingam Munusamy ◽  
Ananda Thangadurai Subramaniam ◽  
Anandkumar Karunakaran ◽  
Abdul Latiff MKM ◽  
...  
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Water Soluble ◽  
Good Resolution ◽  
Limit Of Quantitation ◽  
Method Development And Validation ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

In the present study we are reporting  dissolution, method development and validation of water soluble vitamins B1, B2 & B6 in bulk and tablet dosage form by HPTLC method. The method is based on separation of the three vitamins using HPTLC. Thin layer chromatographic plates coated with silica gel 60F254 as the stationary phase and acetonitrile:water (6:4 v/v) as mobile phase. The chromatographic analysis was carried out in the reflectance and absorbance mode at 280 nm. The method was validated with respect to linearity, accuracy and precision, limit of detection and limit of quantitation. It was then applied for analysis of vitamins B1, B2 & B6 in combined tablet dosage form. The above method developed was reproducible with good resolution and the results of analysis have been validated with correlation coefficient of 0.9990

scholarly journals Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Hesperidin and Diosmin in the Pharmaceutical Dosage Form

2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Doddi Srilatha ◽  
Mahesh Nasare ◽  
Borra Nagasandhya ◽  
Valluri Prasad ◽  
Prakash Diwan
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Cost Effective ◽  
Simultaneous Estimation ◽  
Good Reproducibility ◽  
Pharmaceutical Dosage Form ◽  
Quality Control Tool ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Control Tool

A simple, rapid, precise and highly selective spectrophotometric method was developed for simultaneous estimation of Hesperidin and Diosmin in tablet dosage form. This method, involves the measurement of absorbances of Hesperidin and Diosmin at the wavelengths of 285 nm (λmax of Hesperidin) and 268 nm (λmax, of Diosmin). The UV spectra’s of Hesperidin and Diosmin prepared in different solvents water, methanol, and acetonitrile and 0.2 N sodium hydroxide were recorded. These two drugs showed good absorbances when dissolved in 0.2 N NaOH. Hence 0.2 N NaOH was selected as the solvent for the method. Two wavelengths 285 and 268 nm were selected which are λmax of two drugs Hesperidin and Diosmin, respectively. Different concentrations of Hesperidin (5–50 μg/mL) and Diosmin (2–24 μg/mL) and a mixture of Hesperidin and Diosmin were prepared, scanned and absorbances were noted at the two wavelengths were fixed for the study. The method showed good reproducibility and recovery with % RSD less than 2. The LOD of Hesperidin and Diosmin was found to be 0.139 μg/mL and 0.048 μg/ml and LOQ of Hesperidin and Diosmin was found to be 0.42 μg/mL and 0.147 μg/mL, respectively. Thus the proposed method was found to be rapid, specific, precise, accurate and cost effective quality control tool for the routine analysis of Hesperidin and Diosmin in bulk and combined dosage form.

scholarly journals DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF BAMIFYLLINE HYDROCHLORIDE IN TABLET DOSAGE FORM

2017 ◽  
Vol 9 (4) ◽  
pp. 76
Author(s):  
Panchumarthy Ravisankar ◽  
Shaheem Sulthana ◽  
Inturi Mary Thanuja ◽  
A. Dihitha Chowdary ◽  
J. Vyshnavi
Keyword(s):  
Dosage Form ◽  
Limit Of Detection ◽  
Hplc Method ◽  
Array Detector ◽  
Pharmaceutical Dosage Form ◽  
Rp Hplc ◽  
Photodiode Array Detector ◽  
Limit Of Quantitation ◽  
Tablet Dosage

Objective: The objective of the current study was to develop and validate a novel RP-HPLC method for determination of bamifylline hydrochloride in pharmaceutical dosage form.Methods: Chromatographic separation was conducted on Agilent technologies-1260 series with the G1311C quaternary pump, eclipse XDB C18 column (4.6 mm i.d. X 250 mm, 5 µm particle sizes) and equipped with photodiode array detector G1315D. Mobile phase consisted of methanol and acetonitrile were mixed in the ratio of 90:10 v/v, was used at a flow rate of 1 ml/min and detection wavelength was set at 263 nm.Results: The retention time for bamifylline hydrochloride was found to be 2.913 min. The calibration was linear (r2= 0.9996) in the concentration range of 2-10 µg/ml. The limit of detection and the limit of quantitation were found to be 0.4825 μg/ml and 1.4621 µg/ml respectively. Recovery of bamifylline hydrochloride in tablet formulation was observed in the range of 99.6-99.8 %. Percentage assay of bamifylline hydrochloride (Bamifix) was found to be 99.4 % w/w.Conclusion: Thus the novel proposed method for bamifylline hydrochloride was found to be feasible for the estimation of bamifylline hydrochloride in bulk as well as a pharmaceutical dosage form. 

scholarly journals METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, DOLUTEGRAVIR AND TENOFOVIR DISOPROXIL FUMARATE IN BULK AND PHARMACEUTICAL DOSAGE FORM USING RP-HPLC AND ITS APPLICATION TO IN-VITRO DISSOLUTION STUDY

2021 ◽  
Vol 10 (4) ◽  
pp. 3202-3207
Author(s):  
K. Nihila
Keyword(s):  
Tenofovir Disoproxil Fumarate ◽  
Dosage Form ◽  
Method Development ◽  
In Vitro Dissolution ◽  
Simultaneous Estimation ◽  
Pharmaceutical Dosage Form ◽  
Dissolution Study ◽  
Rp Hplc ◽  
Tablet Dosage

A simple, rapid, and economical method has been developed for the simultaneous estimation of the latest FDA approved antiviral drug combination, Dolutegravir, Lamivudine, and tenofovir disoproxil fumarate in tablet dosage form using Shimadzu LC-20 AT HPLC with a Phenomenex Luna column compartment., the method was developed using HPLC graded methanol with o-phosphoric acid as a mobile phase and successfully validated the developed method as per the ICH guidelines. The method was found to be linear, accurate, precise, robust, and rugged. The limit of detection and the limit of quantification was found to be 2.6μg/ml and 8.18μg/ml for Dolutegravir, 14.63 μg/ml and 44.35 μg/ml for Lamivudine and 16.43 μg/ml and 49.81 μg/ml for tenofovir disoproxil fumarate respectively. The retention time was found to be 3.0, 2.3 and 2.7 min for Dolutegravir, Lamivudine and tenofovir disoproxil fumarate respectively. All of assessed parameters complied with the acceptance criteria hence indicated the usefulness of the RP-HPLC method for the determination of assay and in-vitro dissolution study for tablet dosage form which contains lamivudine, tenofovir disoproxil fumarate, and dolutegravir active substances. Hence the method can be applied for routine quality control of the drugs.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF OLMESARTAN AND HYDROCHLOROTHIAZIDE BY UV SPECTROSCOPY

2021 ◽  
Vol 6 (8) ◽  
pp. 17-31
Author(s):  
Rathod Dipak ◽  
Dubey Archana ◽  
Chaturvedi Prerna
Keyword(s):  
Spectrophotometric Method ◽  
Dosage Form ◽  
Method Development ◽  
Limit Of Detection ◽  
Uv Spectroscopy ◽  
Pharmaceutical Dosage Form ◽  
Water Solvent ◽  
Double Beam ◽  
Beer's Law ◽  
Beer’S Law

In the present work a simple, inexpensive, rapid, easy, sensible and reproducible UV Spectrophotometric method has been developed and validated for determination of Olmesartan (OLM) and Hydrochlorothiazide (HCT) in bulk drug and pharmaceutical dosage form. A simple double beam UV spectrophotometric method has been developed using area under curve method and validated with different parameters such as linearity, precision, Accuracy, limit of detection (LOD), Limit of Quantification (LOQ), accuracy as per ICH guidelines. UV-visible spectrophotometric method, measurement of absorption at maximum wavelength in 10 ml methanol and volume make with water solvent system as reference OLM and HCT were found to be at 256 nm and 276 nm respectively. The drug obeyed the Beer’s law and showed good correlation. Beer’s law was obeyed in concentration range 2-32 µg/ml for Olmesartan and Hydrochlorothiazide respectively with correlation coefficient was 0.999. LOD values for OLM and HCT were found to be 0.056 µg/mL and 0.1050 µg/mL respectively and LOQ values for OLM and HCT were found 0.1698 µg/mL and 0.3183 µg/mL respectively. The proposed method is precise, accurate and reproducible and can be used for routine analysis of OLM and HCT in bulk and pharmaceutical dosage form.

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