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Relevant bibliographies by topics / Stability Indicating Assay Method (SIAM's)

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Academic literature on the topic 'Stability Indicating Assay Method (SIAM's)'

Author: Grafiati

Published: 4 June 2025

Last updated: 23 June 2025

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Journal articles on the topic "Stability Indicating Assay Method (SIAM's)"

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A., R. Pathade V. C. Gurumukhi S. S. Chalikwar Kanchan R. Patil. "DEVELOPMENT, VALIDATION AND STABILITY INDICATING HPLC METHOD: AN OVERVIEW." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 04 (2019): 8401–12. https://doi.org/10.5281/zenodo.2652049.

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<em>The objective of this overview is coverage of development of RP-HPLC method, its validation and evaluation of stability indicating method. .Here, short comings of reported HPLC methods with respect to</em><em> regulatory aspects was highlighted. Stability-indicating assay method (SIAM) was used to differentiate the API from its potential decomposition product. Regulatory guidance status in ICH Q1A (R2), ICH Q3B (R2), Q6A, and FDA 21 CFR section 211 requires validated stability indicating methods. Force degradation of drug is required to demonstrate the specificity when developing SIAMs. For this purpose, the stability indicating methods was adopted. Force degradation of drug standard and drug product is carried out under different conditions to determine the analytical method was robust Here, the separation of all degradation products, establishment of mass balance, stress testing of drug product, development of SIAMs for combination products, etc. was also addressed. Systematic approaches for the development of stability indicating methods are discussed.</em> <strong>Keywords: </strong><em>HPLC; Stability Indicating Method; Analytical Development; Validation.</em>

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2

Pisal, Pooja, Ganesh Nigade, Amol Kale, and Smita Pawar. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ASPIRIN, ROSUVASTATIN, CLOPIDOGREL IN BULK AND PHARMACEUTICAL DOSAGE FORM." International Journal of Pharmacy and Pharmaceutical Sciences 10, no. 10 (2018): 50. http://dx.doi.org/10.22159/ijpps.2018v10i10.28329.

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Objective: To develop a novel, accurate, precise and linear reverse phase high-performance liquid chromatography (RP-HPLC) and Stability Indicating Assay Method (SIAMs) for simultaneous, qualitative and quantitative estimation of aspirin, rosuvastatin and clopidogrel in bulk and pharmaceutical dosage form as per International Conference on Harmonization (ICH) guidelines.Method: In the present work, good chromatographic separation was achieved by isocratic method using a BISCOF HPLC C18 column (250 mm ×4.6, 5 µm) and a mobile phase consisting of water at pH 2.51 with 0.1 % (v/v) orthophosphoric acid (OPA): acetonitrile in the ratio 50:50, at a flow rate of 1 ml/min. The effluents obtained were monitored at 237 nm with the UV-visible detector.Results: The retention time of aspirin, rosuvastatin, and clopidogrel was found to be 4.3 min, 7.6 min and 16.6 min respectively. For linearity seven-point calibration curves were obtained in a concentration range from 1-7 µg/ml for aspirin, rosuvastatin and clopidogrel with correlation coefficient 0.999, 0.9989, 0.9988 respectively. The high recovery values (99%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveal that the method is precise. In the present study stability indicating an RP-HPLC method for the combination was tested by degrading the drugs together under various stress condition like acid, base and neutral hydrolysis, oxidation, thermal and photolytic stress which is recommended by ICH.Conclusion: The developed RP-HPLC method is simple, economic, specific, accurate and precise for the simultaneous estimation of aspirin, rosuvastatin, and clopidogrel in the combined capsule dosage form. The developed stability indicating analytical method can be used to check the stability of the compounds and was found suitable to determine % degradation of drugs in pharmaceutical dosage form.

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Thoppil, Simmy O., and P. D. Amin. "Trimetazidine: stability indicating RPLC assay method." Journal of Pharmaceutical and Biomedical Analysis 25, no. 2 (2001): 191–95. http://dx.doi.org/10.1016/s0731-7085(00)00483-0.

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4

Rajadhyaksha, Namita S., Satish P. Jain, and Purnima D. Amin. "Carbamazepine: Stability Indicating HPLC Assay Method." Analytical Letters 40, no. 13 (2007): 2506–14. http://dx.doi.org/10.1080/00032710701583557.

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5

Al-Masri, R., and M. Al-Mardini. "STABILITY-INDICATING HPLC ASSAY METHOD OF LOVASTATIN." Bulletin of Pharmaceutical Sciences. Assiut 28, no. 2 (2005): 185–89. http://dx.doi.org/10.21608/bfsa.2005.65287.

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6

Garcia, Cássia V. "Stability-Indicating HPLC Method for Posaconazole Bulk Assay." Scientia Pharmaceutica 80, no. 2 (2012): 317–27. http://dx.doi.org/10.3797/scipharm.1111-11.

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7

Sangeetha, M., Tirumala ., and Nagamallika . "STABILITY INDICATING RP-LC ASSAY METHOD FOR CARISOPRODOL." International Journal of Current Pharmaceutical Research 9, no. 6 (2017): 79. http://dx.doi.org/10.22159/ijcpr.2017v9i6.23434.

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Objective: A reverse phase stability-indicating HPLC method was developed for the determination of Carisoprodol in pharmaceutical dosage forms. The chromatographic elution was achieved on C18, 250 mm × 4.6 mm, 5-μm particle size column.Methods: The mobile phase contains a mixture of water and acetonitrile in ratio of 60:40 v/v. The flow rate was 1.0 ml min-1 and was detected by Refractive index detector.Results: The method was proven to be linear over a range of 1 to 4 mg/ml with a mean correlation coefficient of 0.99998. The %mean recovery is in the range of 100.55% to 101.11% and %RSD was less than 1.0% between preparations. The % RSD for Assay results of initial sample preparation in different intervals of 0hr, 24 h, 30 h and 48 h was less than 1.0%. To establish stability-indicating capability of the method, drug product was subjected to the stress conditions of acid, base, oxidative, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from Carisoprodol.Conclusion: The developed method was validated as per international ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

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Saravanan, G., B. M. Rao, M. Ravikumar, M. V. Suryanarayana, N. Someswararao, and P. V. R. Acharyulu. "A Stability-Indicating LC Assay Method for Bicalutamide." Chromatographia 66, no. 3-4 (2007): 219–22. http://dx.doi.org/10.1365/s10337-007-0280-0.

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Desai, Namita D., Pirthipal P. Singh, Purnima D. Amin, and Satishkumar P. Jain. "Stability-Indicating LC Method for Assay of Cholecalciferol." Chromatographia 69, no. 3-4 (2008): 385–88. http://dx.doi.org/10.1365/s10337-008-0914-x.

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Rao, B. Mallikarjuna, Arpita Chakraborty, M. K. Srinivasu, et al. "A stability-indicating HPLC assay method for docetaxel." Journal of Pharmaceutical and Biomedical Analysis 41, no. 2 (2006): 676–81. http://dx.doi.org/10.1016/j.jpba.2006.01.011.

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Books on the topic "Stability Indicating Assay Method (SIAM's)"

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Rp-Hplc Stability Indicating Assay and Simultaneous Estimation Method for the Combination of Glecapravir and Pibrentasvir in Tablet Dosage Form. Independently Published, 2020.

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Book chapters on the topic "Stability Indicating Assay Method (SIAM's)"

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D. China Babu, Dr, G. Sai Sri Harsha, G. Venkateswarlu, M. Alagusundaram, Shailendra Singh Narwariya, and SK Aleesha. "STABILITY INDICATING BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF APALUTAMIDE - APALUTAMIDE D3 BY USING ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY IN HUMAN PLASMA." In Futuristic Trends in Pharmacy & Nursing Volume 3 Book 4. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2024. http://dx.doi.org/10.58532/v3bipn4p1ch3.

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A simple, convenient, specific,precise and highly conventional stability indicating ultra performance liquid chromatographic diode array method was developed for the quantification of Apalutamide in human plasma. The phenomenex Luna (100x4.6x5µ) column was used for apalutamide separation and mobile phase was composed with 5 mM ammonium fumarate and acetonitrile in the ratio of 15:85 v/v and buffer pH 3.5 was adjusted with glacial acetic acid and detected at 345 nm. The Apalutamide D3 used as internal standard and K2 EDTA used as coagulant.The liquid liquid extraction process used for extraction of drug from human plasma with tert butyl methyl ether. The retention times of Apalutamide and Apalutamide D3 (ISTD) was 1.48 min & 1.97 min respectively. The assay of the method was validated in human plasma in the concentration range from 307.26-200013.87 pg/ml with the accuracy and precision ranging from 3.86 to 4.87. Recovery studies were found to be 103.79%, 90.93% & 96.83% for HQC, MQC and LQC respectively. The stability of the drug was evaluated in human plasma with different conditions of auto-sampler, freeze-thaw, bench top, short term and long term stability studies were performed. The method was proved as highly sensitive and selective for the quantification of Apalutamide and determined at picogram level. There was no matrix effect observed and proved as a stability indicating method.

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Godela, Ramreddy, Yagnambhatla Rajendra, Kranthi Kumar Pola, Dr Beda Durgaprasad, and Rani Dumpala. "IMPLEMENTATION OF GREEN SOLVENT SYSTEM FOR THE ANALYSIS OF ADAPALENE IN BULK AND TOPICAL GEL FORMULATION BY RP-HPLC." In Futuristic Trends in Pharmacy & Nursing Volume 2 Book 25. Iterative International Publishers, Selfypage Developers Pvt Ltd, 2023. http://dx.doi.org/10.58532/v2bs25p2ch3.

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A simple and rapid stabilityindicating, RP-HPLC method was ascertained to determine adapalene in bulk and gel formulation. Separation was achieved on enable C18 column (150 x 4.6mm; 5μm) under the isocratic mode of elution by using mobile system mixture of green solvents tetrahydrofuran and methanol (30:70 V/V). The flow rate was maintained at 1.0 ml/min with runtime 10min. UV detection was done at 360 nm. The method was found to be linear for series concentration ranges from 20-100µg/ml. The limit of detection and quantification were found to be 3.27and 0.025µg/ml. Results of precision and accuracy obtained were within the limits. The suggested approach was effectively employed for the determination of adapalene in a labelled formulation (gel), with a % assay of 99%. The suggested method's stability-indicating capacity is shown by evaluating forced degradation samples in which the peak purity of adapalene is determined as well as the resolution of degradant from the analyte peak. The collected findings demonstrate that the provided approach is a stability indicating method. The stated HPLC method has been verified in terms of specificity, precision, sensitivity, accuracy, linearity, and robustness according to ICH

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Sakinala, Padmavathi, Harini Vahika, Ramu Bhadrama raju, Yeellanki Krishnaveni, K. Santhosh, and Sandeep Attinti. "RP-HPLC Method Development and Validation of Stability Indicating Assay for Simultaneous Determination of Pantoprazole, Diclofenac, Chlorzoxazone in Pharmaceutical Dosage Form." In Pharmaceutical Science: New Insights and Developments Vol. 1. BP International, 2024. https://doi.org/10.9734/bpi/psnid/v1/3081.

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