scholarly journals METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF FLUPHENAZINE USINGSIMPLE UV SPECTROPHOTOMETRIC METHOD FOR DETERMINATION IN BULK AND MARKETED DOSAGE FORMS

2021 ◽  
Vol 10 (4) ◽  
Keyword(s):  
Spectrophotometric Method ◽  
Method Development ◽  
Dosage Forms ◽  
Forced Degradation ◽  
Forced Degradation Studies ◽  
Degradation Studies

scholarly journals RP-HPLC assay method development for Paracetamol and Lornoxicam in combination and characterization of oxidative degradation products of Lornoxicam

2013 ◽  
Vol 19 (4) ◽  
pp. 471-484
Author(s):  
Pritam Jain ◽  
Miketa Patel ◽  
Amar Chaudhari ◽  
Sanjay Surana
Keyword(s):  
Method Development ◽  
Degradation Products ◽  
Oxidative Degradation ◽  
Assay Method ◽  
Forced Degradation ◽  
Control Analysis ◽  
Reverse Phase ◽  
Solution Form ◽  
Forced Degradation Studies ◽  
Degradation Studies

A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Paracetamol and Lornoxicam from tablets and to characterize degradation products of Lornoxicam by reverse phase C18 column (Inertsil ODS 3V C-18, 250 x 4.6 mm, 5 ?). The sample was analyzed using Buffer (0.02504 Molar): Methanol in the ratio of 45:55, as a mobile phase at a flow rate of 1.5 mL/min and detection at 290 nm. The retention time for Paracetamol and Lornoxicam was found to be 2.45 and 9.40 min respectively. The method can be used for estimation of combination of these drugs in tablets. The method was validated as per ICH guidelines. The linearity of developed method was achieved in the range of 249.09 - 747.29 ?g/mL (r2=0.9999) for Paracetamol and 4.0125 - 12.0375 ?g/mL (r2=0.9999) for Lornoxicam. Recoveries from tablets were between 98 and 102%. The method was validated with respect to linearity, accuracy, precision, robustness and forced degradation studies which further proved the stability-indicating power. During the forced degradation studies lornoxicam was observed to be labile to alkaline hydrolytic stress and oxidative stress (in the solution form). However, it was stable to the acid hydrolytic, photolytic and thermal stress (in both solid and solution form). The degraded products formed were investigated by electrospray ionization (ESI) time-of-flight mass spectrometry, NMR and IR spectroscopy. A possible degradation pathway was outlined based on the results. The method was found to be sensitive with a detection limit of 0.193 ?g/ml, 2.768 ?g/ml and a quantitation limit of 0.638 ?g/ml, 9.137 ?g/ml for lornoxicam and paracetamol, respectively. Due to these attributes, the proposed method could be used for routine quality control analysis of these drugs in combined dosage forms.

scholarly journals ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF LANSOPRAZOLE BY RP-HPLC

2018 ◽  
Vol 6 (4) ◽  
pp. 21-29
Author(s):  
Madhavi K Meher ◽  
Charushila Bhangale ◽  
Ramdas Dholas ◽  
Vandana Aher Prashant ◽  
Rohan Pawar
Keyword(s):  
Chromatographic Method ◽  
Method Development ◽  
Limit Of Detection ◽  
Forced Degradation ◽  
Limit Of Quantification ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Reciprocating Pump ◽  
Liquid Chromatographic

The objective of this work is to develop a rapid, precise, accurate and sensitive revere phase liquid chromatographic method and Forced degradation studies for the estimation of Lansoprazole. The chromatographic method was standardized for Lansoprazole using Shimadzu HPLC model reverse phase analytical Inspire grace C18 column (250 mm x 4.5 mm, 5mm particle size) with PC-3000-M Reciprocating Pump (40 Mpa) and UV-3000-M Detector, at 285nm and flow rate of 0.8 ml/min. The mobile phase consists of 80:20 Methanol: water. The linearity of proposed method was investigated in the range of 10-50 µm/ml (R2 = 0.999) of Lansoprazole. The limit of detection (LOD) was found to be 0.12 mm/ml. The limit of quantification (LOQ) was found to be 0.36 mg/ml. The retention time of Lansoprazole found to be 5.4 min. The method was statistically validated and % RSD was found to be less than 2 indicating high degree of accuracy and precision. Hence proposed method can be successfully applied for the estimation of Lansoprazole in further studies. Keywords: Lansoprazole, RP-HPLC, Chromatogram, validation, estimation.

scholarly journals METHOD DEVELOPMENT AND VALIDATION OF FORCED DEGRADATION STUDIES OF CARVEDILOL BY USING UV SPECTROSCOPY

2016 ◽  
Vol 03 (02) ◽  
pp. 53-56
Author(s):  
Kamalakannan Dhanapal ◽  
Ananda T Subramaniam ◽  
Anandakumar Karunakaran ◽  
Jambulingam Munusamy ◽  
Devi Velmurugan
Keyword(s):  
Method Development ◽  
Uv Spectroscopy ◽  
Forced Degradation ◽  
Forced Degradation Studies ◽  
Method Development And Validation ◽  
Degradation Studies ◽  
Development And Validation

scholarly journals Forced degradation of tacrolimus and the development of a UHPLC method for impurities determination

2019 ◽  
Vol 69 (3) ◽  
pp. 363-380 ◽  
Author(s):  
Tanja Rozman Peterka ◽  
Tina Trdan Lušin ◽  
Jure Bergles ◽  
Zoran Ham ◽  
Rok Grahek ◽  
...  
Keyword(s):  
High Performance ◽  
Gradient Elution ◽  
Dosage Forms ◽  
Forced Degradation ◽  
Chromatography Method ◽  
Pharmaceutical Dosage Forms ◽  
Thermal Light ◽  
Forced Degradation Studies ◽  
Degradation Studies ◽  
Liquid Chromatography Method

Abstract An ultra-high performance liquid chromatography method for simultaneous determination of tacrolimus impurities in pharmaceutical dosage forms has been developed. Appropriate chromatographic separation was achieved on a BEH C18 column using gradient elution with a total run time of 14 min. The method was applied to analyses of commercial samples and was validated in terms of linearity, precision, accuracy, sensitivity and specificity. It was found to be linear, precise and accurate in the range of 0.05 to 0.6 % of the impurities level in pharmaceutical dosage forms. Stability indicating power of the method was demonstrated by the results of forced degradation studies. The forced degradation study in solution revealed tacrolimus instability under stress alkaline, thermal, light and photolytic conditions and in the presence of a radical initiator or metal ions. The drug was stable at pH 3–5. Solid-state degradation studies conducted on amorphous tacrolimus demonstrated its sensitivity to light, elevated temperature, humidity and oxidation.

scholarly journals Development and Validation of RP-HPLC Assay Method for Vildagliptin Using Qbd Approach and Its Application to Forced Degradation Studies

2016 ◽  
Vol 8 (03) ◽  
Author(s):  
Meetali M. Chaphekar ◽  
Purnima Hamrapurkar
Keyword(s):  
Method Development ◽  
Accurate Determination ◽  
Interaction Effects ◽  
Hplc Method ◽  
Assay Method ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Forced Degradation Studies ◽  
Degradation Studies

The concept of Quality by design (QbD) has recently gained importance in the area of analytical method development and involves understanding of the critical factors and their interaction effects by a desired set of experiments. So, the present work describes the development of Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method by QbD approach using Design of Experiments and subsequent validation for analysis of Vildagliptin in bulk drug and its pharmaceutical formulation. An efficient experimental design based on systematic scouting of all three key components of the RP‐HPLC method (Buffer pH, Organic Phase-% acetonitrile, Organic Modifier-Methanol) is presented. The significance and interaction effects of these parameters on the response variables (Retention time and tailing factor) were evaluated through statistical analysis tools like Analysis of Variance (ANOVA) and plots which revealed the final chromatographic conditions of the method. The developed method was validated and Forced degradation studies were also carried out in order to determine the stability-indicating nature of the method. The chromatographic separation was achieved on Jasco CrestPack RP C18 (250 × 4.6 mm, 5μ) column using Buffer (pH 6): Acetonitrile: Methanol (70:10:20 v/v) as mobile phase and detection was done using Photo-Diode Array (PDA) detector at 210 nm. The developed method of Vildagliptin is linear over a range of 5-15μg/ml having correlation coefficient R2 value as 0.999. The %RSD for precision and accuracy of the method was found to be less than 2%. Forced Degradation studies revealed that the method was found to be stability-indicating. The results showed that the proposed method is suitable for the precise and accurate determination of Vildagliptin in bulk and its formulation.

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