'Stability indicating' presentation slideshows

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VALIDATION AND CONTROL OF BIOANALYTICAL MASS SPECTROMETRY METHODS

VALIDATION AND CONTROL OF BIOANALYTICAL MASS SPECTROMETRY METHODS. 0 2. ANTIDEPRESSANT DRUGS. M.W.306.23. SERTRALINE NOR-SERTRALINE. M.W.292.20. MS-MS SPECTRA of Sertraline and Nor-Sertraline. Sertraline. Nor-Sertraline. TIC (MRM) of Nor-Sertraline (A) and Sertraline (B).

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Workshop on Quality Assurance and GMP of Multisource HIV /AIDS medicines

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Roadmap of stability studies for Biosimilar product development

Roadmap of stability studies for Biosimilar product development. Dr. Rashbehari Tunga Head Biotech Stelis Biopharma. Index. Introduction Regulatory guideline related to stability Summary of stability requirement at various stage

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Development and validation of a stability indicating RP-HPLC method for simultaneous determination of Lamivudine and Sta

A simple, rapid, precise, and accurate stability-indicating, reversed phase (RP) HPLC assay method was developed and validated for simultaneous estimation of Lamivudine (3TC) and Stavudine (d4T) in bulk drugs and commercial tablets. The method has shown adequate separation of 3TC and d4T from their degradation products. Separation was achieved on a Kromasil C8 (250mm×4.6mm i.d; 5 µm) column at a detection wavelength of 265nm, using a mobile phase consisting of acetonitrile–0.02M ammonium acetate buffer (pH 4.5) in a gradient elution mode at a flow rate of 1 ml/min. The retention times for lamivudine and stavudine were found to be 13.66 and 16.51 min respectively Lamivudine (3TC), stavudine (d4T) and their combination drug product were subjected to acid, base and neutral hydrolysis, oxidation, thermal and photolytic stress conditions and the stressed samples were analyzed by the proposed method. Validation of the method was carried out as per ICH guidelines. Quantitation was achieved with UV detection at 265 nm based on peak area with linear calibration curves at concentration ranges 2.5-50µg/ml for 3TC and 0.5-10µg/ml for d4T (R2 > 0.9999 for both drugs). The limits of detection were 0.82 µg/ml and 0.33 µg/ml for lamivudine and stavudine, respectively. The method was found to be specific and stability indicating as no interfering peaks of degradants and excipients were observed. The proposed method is hence suitable for application in quality-control laboratories for quantitative analysis of both the drugs individually and in combination dosage forms, since it is simple and rapid with good accuracy and precision

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A Validated specific Stability-indicating RP-HPLC method for Aripiprazole and its related substances

A validated specific stability indicating reversed-phase liquid chromatographic method was developed for the quantitative determination of Aripiprazole and its related substances in bulk samples, pharmaceutical dosage forms in presence of degradation products. Forced degradation studies were performed on bulk sample of Aripiprazole as per ICH prescribed stress conditions using acid, base, oxidative, thermal stress and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed during basic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked with Aripiprazole. Good resolution between the peaks corresponds to impuritiy-1, degradation products from the analyte were achieved on YMC PACK C18 column using the mobile phase consists a mixture of Sodium dihydrogen Orthophosphate dehydrate with1-Hexane sulfonic acid sodium pH adjusted to 3.0 with ortho-phosphoric acid in water and Acetonitrile using a simple linear gradient. The detection was carried out at 215 nm.The stressed test solutions were assayed against the qualified working standard of Aripiprazole and the mass balance in each case was in between to 98.9-100.1% indicating that the developed LC method was stability-indicating. Validation of the developed LC method was carried out as per ICH requirements. The developed method was found to be suitable to check the quality of bulk samples of Aripiprazole at the time of batch release and also during its storage (Long term and accelerated stability).

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Stability indicating RP-HPLC method for simultaneous determination of Terlipressin in pure and pharmaceutical formulatio

A simple, selective, precise and stability indicating High Performance Liquid Chromatographic (HPLC) method of analysis of Terlipressin in pure and pharmaceutical dosage form was developed and validated. The chromatographic conditions comprised of a reversed-phase C18 column (250 x 4.6 mm), 5 µ with a mobile phase consisting of a mixture of Acetonitrilemonobasic potassium phosphate solution (35:65v/v) and pH adjusted to 3.5. Flow rate was 1.5 mL / min. Detection was carried out at 280 nm. The retention time of Terlipressin was 10.05 min. Terlipressin was subjected to acid and alkali hydrolysis, oxidation, photochemical degradation and thermal degradation. The linear regression analysis data for the calibration plots showed good linear relationship in the concentration range 2-12µg/ml. The value of correlation coefficient, slope and intercept were, 0.9995, 1848.2and 62.786, respectively. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, photochemical and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.

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