scholarly journals Method Development and Validation of Pitavastatin Calcium and its Degradation Behavior under varied Stress Conditions by UV Spectrophotometric methods

2019 ◽  
Vol 18 (2) ◽  
pp. 159-169
Author(s):  
S Niranjani ◽  
K Venkatachalam
Keyword(s):  
Method Development ◽  
Correlation Coefficients ◽  
Pharmaceutical Formulations ◽  
Stability Study ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Pitavastatin Calcium ◽  
Development And Validation

UV spectrophotometric methods for the determination of pitavastatin calcium in pure and pharmaceutical dosage forms were developed and validated as per ICH guidelines. The standard pitavastatin calcium solutions were scanned between the ranges of 200-400 nm. The maximum absorbance of pitavastatin calcium in DMF (method A), HCl (method B) and NaOH (method C) was recorded at 266 nm. They obeyed Beers law concentration in the range of 10-45 μg/ml (method A), 0.25-2.0 μg/ml (method B) and 0.25-2.0 μg/ml (method C) with correlation coefficients 0.9996, 0.9998 and 0.9998 respectively. Stability study showed high stability of pitavastatin calcium in acidic, alkaline medium and at high temperature, but undergone degradation in oxidative stress condition. The developed methods were validated for linearity, precision, accuracy, LOD, LOQ, ruggedness, robustness and recovery studies. The proposed methods can be successfully used for the routine quality control analysis of pitavastatin calcium in bulk and commercial pharmaceutical formulations. Dhaka Univ. J. Pharm. Sci. 18(2): 159-169, 2019 (December)

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.

scholarly journals RP-HPLC method development and validation for estimation of rivaroxaban in pharmaceutical dosage forms

2013 ◽  
Vol 49 (2) ◽  
pp. 359-366 ◽  
Author(s):  
Mustafa Çelebier ◽  
Tuba Reçber ◽  
Engin Koçak ◽  
Sacide Altinöz
Keyword(s):  
Method Development ◽  
Internal Standard ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Method Development And Validation ◽  
Hplc Method Development ◽  
Development And Validation ◽  
Tablet Dosage

Rivaroxaban, an anti-clotting medication, acts at a crucial point in the blood-clotting process and stops the formation of blood clots. In this study, RP-HPLC method was developed for the determination of rivaroxaban in tablets (Xarelto® (10 mg)). Phenomenex Luna 5 µm C18 100 Å LC Column (250 x 4.6 mm) was used at 40 ºC. Isocratic elution was performed with ACN:Water (55:45 v/v) mixture. The flow rate was 1.2 mL min-1 and UV detection was at 249 nm. Internal standard (Caffeine) and rivaroxaban were eluted within 2.21 and 3.37 minutes, respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range 0.005 - 40.0 µg mL-1. The method was accurate, precise, robust and rapid. Thus, it was applied successfully for the quality control assay of rivaroxaban in tablet dosage form.

DEVELOPMENT AND VALIDATION OF RP-HPLC-PDA METHOD FOR THE ESTIMATION OF SARPOGRELATE HYDROCHLORIDE IN BULK AND DOSAGE FORMS

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (04) ◽  
pp. 77-80
Author(s):  
M Vijaya Lakshmi ◽  
◽  
K Hima Bindu ◽  
M. Pravallika ◽  
B. N. Nalluri
Keyword(s):  
Dosage Forms ◽  
Hplc Method ◽  
Control Analysis ◽  
Pharmaceutical Dosage Forms ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Anti Platelet Drug ◽  
Sarpogrelate Hydrochloride ◽  
The Mean ◽  
Development And Validation

A simple and precise RP-HPLC method has been developed and validated for the estimation of sarpogrelate hydrochloride, an anti-platelet drug in bulk and pharmaceutical dosage forms. Sarpogrelate is an antagonist at 5HT2A and 5HT2B receptors which blocks serotonin induced platelet aggregation and has application in the treatment of diseases including diabetes mellitus, Raynaud’s disease, angina pectoris and atherosclerosis. Chromatography was carried out on a Phenomenex C18 (250 x 4.6mm, 5μm) column with a mobile phase of 10mM ammonium acetate and acetonitrile (45:55% v/v). The flow rate was 1.2mL/min. The detection wavelength was carried out at 220nm. The retention time is 3.356 minutes for sarpogrelate hydrochloride. The linearity was found in the range of 10-50 μg/ml (R = 0.999) and % RSD is less than 2%. The mean recoveries obtained for sarpogrelate hydrochloride were in the range of 98.73-100.67%. The method is validated as per ICH guidelines and can be applied for the estimation of percentage purity in Sarpogrelate hydrochloride for quality control analysis in bulk and its dosage forms.

Development and validation of a new stability indicating RP-UFLC method for the estimation of Bosentan

2021 ◽  
pp. 4445-4451
Author(s):  
Kalyani Lingamaneni ◽  
Mukthinuthalapati Mathrusri Annapurna
Keyword(s):  
Blood Pressure ◽  
Pharmaceutical Formulations ◽  
Buffer Solution ◽  
Pharmaceutical Dosage Forms ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Stress Degradation ◽  
Pulmonary Arterial ◽  
Development And Validation ◽  
Alkaline Oxidation

A new stability-indicating RP-UFLC method has been developed for the estimation of Bosentan in pharmaceutical dosage forms and the method was validated. Bosentan is used to lower the high blood pressure in lungs (pulmonary arterial hypertension). Bosentan acts by blocking the actions of endothelin -1and thereby lowers the blood pressure. Mobile phase mixture consisting of sodium acetate (pH 5.0) buffer solution and acetonitrile (50: 50 v/v) with flow rate 0.7 mL/min were the optimized chromatographic conditions (Detection wavelength 254 nm) for the present study. Linearity was observed in the concentration range of 0.1–100 μg/mL (R2 = 0.9998) with regression equation y = 126698 x – 392.49. The LOQ was found to be 0.08964 µg/mL and the LOD was found to be 0.02913 µg/mL. Stress degradation studies such as acidic, alkaline, oxidation, photolysis and thermal degradations were performed by exposing Bosentan and finally the proposed method was validated as per ICH guidelines. The assay of Bosentan was conducted by applying the proposed method to the marketed formulations. The proposed method is simple, specific, precise, and accurate and can be applied for the estimation of pharmaceutical formulations.

scholarly journals Estimation of Levocetirizine in Bulk and Formulation by First Order Derivative Area under Curve UV-Spectrophotometric Methods.

2016 ◽  
Vol 2 (1) ◽  
pp. 09
Author(s):  
Pandurang Tukaram Mane
Keyword(s):  
Area Under Curve ◽  
Pharmaceutical Formulations ◽  
Order Derivative ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
First Order ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Significant Difference

Simple, fast and reliable spectrophotometric methods were developed for determination of Levocetirizine in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 235-243 nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Levocetirizine using 5-25?g/ml (r=0.9994) for first order Derivative Area under Curve spectrophotometric method. The proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Levocetirizine in pharmaceutical formulations.

scholarly journals VISIBLE SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION OF IMATINIB IN BULK AND FORMULATION

2020 ◽  
pp. 63-67
Author(s):  
SMITA KUMBHAR ◽  
VINOD MATOLE ◽  
YOGESH THORAT ◽  
ANITA SHEGAONKAR ◽  
AVINASH HOSMANI
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Uv Spectrum ◽  
Colored Complex ◽  
Pharmaceutical Dosage Forms ◽  
Highly Sensitive ◽  
Method Development And Validation ◽  
Development And Validation

Objective: A new, simple, sensitive, precise and reproducible UV visible spectrophotometric method was developed for the determination of Imatinib in pharmaceutical formulations with alizarin. Methods: The method is based on formation of yellow-colored complex. The UV spectrum of Imatinib in methanol showed λ max at 431 nm. Beer’s law is valid in the concentration range of 10-70 μg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-70 μg/ml with regression equation y =0.013x-0.017 and regression correlation coefficient r2= 0.997. Moreover, the method was found to be highly sensitive with LOD (4.3μg/ml) and LOQ (13.07μg/ml). Conclusion: Based on results the proposed method can be successfully applied for the assay of Imatinib in various pharmaceutical dosage forms.

scholarly journals Estimation of Ofloxacin in Bulk and Formulation by Second Order DerivativeUV-Spectrophotometric Methods

2015 ◽  
Vol 1 (5) ◽  
pp. 217
Author(s):  
Shivaji Shinde ◽  
Santosh Jadhav ◽  
Rekha Kharat ◽  
Afaque Ansari ◽  
Ashpak Tamboli
Keyword(s):  
Area Under Curve ◽  
Pharmaceutical Formulations ◽  
Second Order ◽  
Order Derivative ◽  
Pharmaceutical Dosage Forms ◽  
Mean Values ◽  
Spectrophotometric Methods ◽  
Ich Guidelines ◽  
Significant Difference

Simple, fast and reliable spectrophotometric methods were developed for determination of Ofloxacin in bulk and pharmaceutical dosage forms. The solutions of standard and the sample were prepared in Methanol. The quantitative determination of the drug was carried out using the second order Derivative Area under Curve method values measured at 295-301nm. Calibration graphs constructed at their wavelengths of determination were linear in the concentration range of Ofloxacin using 2-10?g/ml (r=0.9947) for second order Derivative Area under Curve spectrophotometric method. All the proposed methods have been extensively validated as per ICH guidelines. There was no significant difference between the performance of the proposed methods regarding the mean values and standard deviations. The developed methods were successfully applied to estimate the amount of Ofloxacin in pharmaceutical formulations.

scholarly journals Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC

2020 ◽  
Vol 10 (4) ◽  
pp. 97-101
Author(s):  
Mithun Rudrapal ◽  
Nazim Hussain
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Reversed Phase ◽  
Hplc Method ◽  
Pharmaceutical Dosage Forms ◽  
Average Percentage ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Development And Validation ◽  
Tablet Dosage

A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms. Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines

scholarly journals Method Development and Validation of Montelukast in API and Pharmaceutical Dosage Form by UV Spectrophotometry

2021 ◽  
Vol 71 (2) ◽  
Author(s):  
Abhishek Chandola ◽  
Meenakshi Bhatt
Keyword(s):  
Dosage Form ◽  
Method Development ◽  
Correlation Coefficients ◽  
Uv Spectrophotometry ◽  
Analysis Method ◽  
Allowable Limit ◽  
Pharmaceutical Dosage Form ◽  
Pharmaceutical Dosage Forms ◽  
Method Development And Validation ◽  
Development And Validation

The present work is done to develop a new simple, rapid, specific, accurate and precise UV spectrophotometric method for Montelukast as API and in pharmaceutical dosage form. The validation of the proposed method was carried out according to the I.C.H guidelines. The wavelength maxima was found 270nm and calibration curves were obtained in the concentration range 5-45?g/ml for montelukast with good correlation coefficients (r2=0.9994.). The precisions of the new method for montelukast was less than the maximum allowable limit (%RSD <2.0) specified by the ICH. Therefore, the method was found to be an accurate, reproducible and sensitive for analysis of montelukast as standard, pharmaceutical dosage forms, and other routine analysis method.

scholarly journals Three Spectrophotometric Methods for Quantitative Analysis of Duloxetine in Presence of its Toxic Impurity: 1-Naphthol

2020 ◽  
Vol 103 (4) ◽  
pp. 972-979 ◽  
Author(s):  
Ibrahim A Naguib ◽  
Nessreen S Abdelhamid ◽  
Basma H Anwar ◽  
Maimana A Magdy
Keyword(s):  
Pharmaceutical Formulations ◽  
Control Analysis ◽  
Aquatic Life ◽  
Spectrophotometric Methods ◽  
Duloxetine Hydrochloride ◽  
Ich Guidelines ◽  
Mean Centering ◽  
Absorbance Difference ◽  
The Mean

Abstract Background Duloxetine hydrochloride (DUL) is a drug used to treat depression and anxiety. 1-Naphthol is a potential toxic impurity of DUL, as it causes hepatotoxicity in humans, and it is harmful to aquatic life. Objective Three simple, selective, rapid, accurate and precise methods were developed and validated according to International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision and selectivity for analysis of duloxetine hydrochloride (DUL) in the presence of its potential toxic impurity 1-Naphthol in different laboratory-prepared mixtures and pharmaceutical formulations. Methods Method (A) is the first derivative of the ratio spectra spectrophotometric (1DD) method which allows determination of DUL at 251 nm and 1-Naphthol at 305.2 nm without interference from each other. Method B (dual wavelength) means that two different wavelengths were chosen to each drug, where the absorbance difference at these two wavelengths is equal to zero to the second drug. The chosen two wavelengths for DUL were 221.4 nm and 235.6, where the absorbance difference for 1-naphthol at these two wavelengths was equal to zero. While the chosen wavelengths for 1-naphthol were 247.8 nm and 297 nm, where the absorbance difference for DUL at these two wavelengths was equal to zero. Method (C) is the mean centering of ratio spectra spectrophotometric (MCR) method, which depends on measuring the mean centered values of ratio spectra of both DUL and 1-Naphthol at 226 nm. Results These methods were validated and agreed with the requirements of ICH guidelines with respect to linearity, accuracy, precision and selectivity. Conclusions The results indicate the ability of developed methods to be used for routine quality control analysis of DUL in bulk and pharmaceutical formulations in the presence of its potential impurity 1-Naphthol.

Sign in / Sign up

Export Citation Format

Share Document