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

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

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. Fo

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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

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3

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 le

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8

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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9

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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10

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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11

Hou, Shuguang, Michael Hindle, and Peter R. Byron. "A stability-indicating HPLC assay method for budesonide." Journal of Pharmaceutical and Biomedical Analysis 24, no. 3 (2001): 371–80. http://dx.doi.org/10.1016/s0731-7085(00)00424-6.

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12

Alam, Prawez, Faiyaz Shakeel, Mohammed H. Alqarni, et al. "Development and Validation of A Stability-Indicating Greener HPTLC Method for the Estimation of Flufenamic Acid." Separations 10, no. 1 (2023): 39. http://dx.doi.org/10.3390/separations10010039.

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The literature on ecofriendly/greener high-performance thin-layer chromatographic (HPTLC) methods for quantifying flufenamic acid (FFA) is scant. In order to develop and validate a stability-indicating greener HPTLC densitometry assay for FFA determination in marketed products, this research was conducted. The ecofriendly eluent system was composed of ethanol–water (70:30 v/v). FFA was measured at 290 nm of wavelength. The greenness scale of suggested analytical assay was derived using “Analytical GREENness (AGREE)” methodology. The suggested stability-indicating HPTLC assay was linear for FFA

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13

Saravanan, G., M. V. Suryanarayana, M. J. Jadhav, M. Ravikumar, N. Someswararao, and P. V. R. Acharyulu. "A Stability-Indicating LC Assay Method for Pemetrexed Disodium." Chromatographia 66, no. 5-6 (2007): 431–34. http://dx.doi.org/10.1365/s10337-007-0309-4.

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14

Naik, CN Prathyusha, and KB Chandra Sekhar. "Reliable and Sensitive Stability Indicating Assay Method of Armodafinil." Journal of Young Pharmacists 10, no. 1 (2018): 52–56. http://dx.doi.org/10.5530/jyp.2018.10.13.

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15

Ahmad, Iqbal, Syed Haider Abbas, Zubair Anwar, et al. "Stability-Indicating Photochemical Method for the Assay of Riboflavin: Lumichrome Method." Journal of Chemistry 2015 (2015): 1–8. http://dx.doi.org/10.1155/2015/256087.

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A stability-indicating photochemical method for the assay of riboflavin (RF) in photodegraded samples and aged vitamin preparations has been developed. It is based on photochemical conversion of RF to lumichrome (LC) in alkaline solution under controlled conditions of light intensity, temperature, pH, time of exposure, and distance. Under these conditions about two-thirds of RF is converted to LC and on the basis of the RF : LC ratio the concentration of RF can be determined in degraded solutions. The method involves the extraction of photolyzed solutions of RF (pH 2.0) with chloroform and det

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16

Alam, Prawez, Faiyaz Shakeel, Mohammed H. Alqarni, et al. "Determination of Cordycepin Using a Stability-Indicating Greener HPTLC Method." Separations 10, no. 1 (2023): 38. http://dx.doi.org/10.3390/separations10010038.

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A wide range of analytical techniques have been reported to determine cordycepin (CDN) in various sample matrices. Nevertheless, greener analytical approaches for CDN estimation are scarce in the literature. As a result, this study was designed to develop and validate a stability-indicating greener “high-performance thin-layer chromatography (HPTLC)” technique for CDN determination in a laboratory-developed formulation. The greener eluent system for CDN detection was ethanol–water (75:25 v/v). At a wavelength of 262 nm, CDN was measured. The greenness scale of the proposed analytical technolog

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17

Sinha, VR, RV Kumar, and JR Bhinge. "A stability-indicating RP-HPLC assay method for 5-fluorouracil." Indian Journal of Pharmaceutical Sciences 71, no. 6 (2009): 630. http://dx.doi.org/10.4103/0250-474x.59544.

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18

Srinivasan, V., H. Sivaramakrishnan, and B. Karthikeyan. "Stability-Indicating RP-HPLC Method for Assay of Silver Lactate." E-Journal of Chemistry 8, no. 2 (2011): 483–90. http://dx.doi.org/10.1155/2011/234640.

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A simple, economic and time-efficient stability-indicating, reverse-phase high-performance liquid chromatographic (RP-HPLC) method has been developed for analysis of silver lactate in the presence of degradation products generated by decomposition. When silver lactate was subjected to acid hydrolysis, base hydrolysis, oxidative, photolytic, humidity and thermal stress, degradation was observed during base hydrolysis, oxidation, humidity and thermal stress. The drug was found to be stable to other stress conditions. Successful chromatographic condition of the drug from the degradation products

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19

Saravanan, G., M. V. Suryanarayana, N. Balaji, N. Someswararao, and N. M. Sekhar. "A Stability-Indicating LC Method for Assay of Topotecan Hydrochloride." Chromatographia 67, no. 1-2 (2007): 179–82. http://dx.doi.org/10.1365/s10337-007-0468-3.

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20

Raju, T. Satyanarayana, K. S. V. Raghavachary, A. Raghupathi Reddy, M. Satish Varma, M. Ravikumar, and P. Yadagiri Swamy. "A Validated and Stability-Indicating LC Assay Method for Valdecoxib." Chromatographia 69, no. 5-6 (2009): 507–11. http://dx.doi.org/10.1365/s10337-008-0933-7.

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21

Vaucher, Lauren C., Clésio S. Paim, Alini D. Lange, and Elfrides E. S. Schapoval. "LC method for telithromycin in tablets: A stability-indicating assay." International Journal of Pharmaceutics 366, no. 1-2 (2009): 82–87. http://dx.doi.org/10.1016/j.ijpharm.2008.09.010.

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22

Khanvilkar, Vineeta. "Stability indicating assay method for estimation of Empagliflozin using HPTLC." Journal of Medical Pharmaceutical and Allied Sciences 14, no. 1 (2025): 7017–23. https://doi.org/10.55522/jmpas.v14i1.6782.

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A planer chromatographic method capable of indicating the stability of the empagliflozin was developed and validated. Separations were achieved on the silica gel 60F254 as the planar stationary phase and a solvent mixture comprising of Chloroform, Toluene, Methyl alcohol, and Methanolic acid mixed in a proportion of 8:4:2:0.1 v/v/v/v. Examination of the band developed for empagliflozin indicated a densito metric value with an retardation factor of 0.33±0.02. The calibration data analysis through linear regression showed a statistically significant correlation (R2 > 0.990) between peak area

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23

Bhardwaj, Shalini, M. K. Gupta, and V. Bhalla. "METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE." International Journal of Drug Regulatory Affairs 3, no. 4 (2018): 24–42. http://dx.doi.org/10.22270/ijdra.v3i4.174.

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A simple and rapid stability indicating, ultra performance liquid chromatographic (UPLC) method was developed and validated for the determination of Nifedipine. The quantitative determination of Nifedipine drug was performed on a Sunniest C-18-HT, 2m, (50 2.1nm) column with gradient elution. For UPLC method, UV detection was made at 335nm. During method validation, parameters such as precision, linearity, stability, robustness and specificity were evaluated, which remained within acceptable limits. Forced degradation studies of Nifedipine were studied under acidic and alkaline stress condition

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24

Kombath, Sonoube, Issa-Bella Balde, Sandra Carret, et al. "Stability-Indicating HPLC Assay for Determination of Idebenone in Pharmaceutical Forms." Journal of Analytical Methods in Chemistry 2015 (2015): 1–5. http://dx.doi.org/10.1155/2015/835986.

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A stability-indicating method was validated for the determination in pharmaceutical forms of idebenone a coenzyme Q10-like compound. The assay was achieved by liquid chromatography analysis using a reversed-phase C18 column and a detector set at 480 nm. The optimized mobile phase consisted of isocratic flow rate at 1.0 mL/min for 3 min with methanol. The linearity of the assay was demonstrated in the range of 3.0 to 8.0 mg/mL with a correlation coefficientr2>0.998. The limits of detection and quantification were 0.03 and 0.05 mg/mL, respectively. The intraday and interday precisions were le

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25

Diksha, Vibhute, Deshpande Anant, Komal Shinde, and Priyanka Wankhede. "Stability Indicating RP-HPLC Method for Posaconazole Assay Using QbD Approach." INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 15, no. 03 (2024): 1401–7. http://dx.doi.org/10.25258/ijpqa.15.3.48.

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The development and optimization of analytical techniques utilizing the quality by design methodology is essential in the pharmaceutical industry. This approach helps in the direction of identifying and optimizing critical parameters during drug development and assesses their impact on key quality attributes. A stability-indicating RP-HPLC method was developed for quantifying posaconazole in bulk and tablet forms utilizing the quality-by-design approach. The Box-Behnken design optimized buffer flow rate, organic modifier percentage, and temperature, affecting retention time, theoretical plate

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26

Deore, Sharada L., Minal A. Mohod, Bhushan A. Baviskar, and Somshekhar S. Khadabadi. "HPTLC validated stability indicating assay method for marketed herbal antihypertensive formulations." Pharmaceutical Methods 4, no. 1 (2013): 11–15. http://dx.doi.org/10.1016/j.phme.2013.06.001.

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27

Walash, Mohamed I., Fathalla Belal, Nahed El-Enany, Manal Eid, and Rania N. El-Shaheny. "Stability-Indicating Spectrofluorimetric Method for the Assay of Ziprasidone in Capsules." Journal of Fluorescence 21, no. 4 (2011): 1659–67. http://dx.doi.org/10.1007/s10895-011-0855-x.

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28

Ezhava, Sindhu, Shaival Shah, Arpit Patwari, and Mahesh Chhabria. "Development and validation of a stability-indicating assay method for naftopidil." JPC - Journal of Planar Chromatography - Modern TLC 29, no. 3 (2016): 195–202. http://dx.doi.org/10.1556/1006.2016.29.3.5.

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29

Ahmad, Iqbal, Syed Haider Abbas, Zubair Anwar, et al. "Stability-Indicating Photochemical Method for the Assay of Thiamine by Spectrophotometry." Journal of Spectroscopy 2018 (2018): 1–7. http://dx.doi.org/10.1155/2018/3178518.

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A stability-indicating photochemical method has been developed for the assay of thiamine (TH) salts in aqueous solution and in fresh and aged vitamin preparations. It is based on the photooxidation of TH by UV irradiation to form thiochrome (TC) in alkaline solution. The TC : TH ratio under controlled conditions of light intensity, temperature, pH, exposure time, and irradiation distance is constant and can be used to determine the concentration of UV irradiated TH solutions. TC, on extraction with isobutanol from the photodegraded solution of TH, has been determined by the UV spectrophotometr

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30

Jain, Hemant K., and Vishal K. Nikam. "FORMULATION DEVELOPMENT AND STABILITY INDICATING HPLC ASSAY OF TABLETS OF APIXABAN." International Journal of Pharmacy and Pharmaceutical Sciences 9, no. 10 (2017): 24. http://dx.doi.org/10.22159/ijpps.2017v9i10.20343.

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Objective: Cost effective formulation development and stability indicating HPLC method for estimation of apixaban in bulk and tablets dosage form.Methods: 32 factorial design was applied to formulate the immediate release tablets of apixaban by using direct compression method. The chromatographic separation was performed on Purospher Star RP-18e (5 µm, 250x4, 6 mm) column and a stability indicating assay method was developed by using HPLC. The mobile phase consists of water: acetonitrile (60:40 v/v) was delivered at a flow rate of 1 ml/min and UV detection at 280 nm. The method was validated w

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31

Rochani, Ankit, Vinh Nguyen, Robin Becker, Walter Kraft, and Gagan Kaushal. "Stability-indicating LC-MS Method for Determination of Stability of Extemporaneously Compounded Buprenorphine Oral Syringes for Neonatal Abstinence Syndrome." Journal of Pediatric Pharmacology and Therapeutics 26, no. 4 (2021): 395–404. http://dx.doi.org/10.5863/1551-6776-26.4.395.

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OBJECTIVE In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography–mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time. METHODS A stability-indicating LC-MS method was developed to map the potential degradation pea

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32

Chaudhari, Yogesh Jagdish, Rama Sadashiv Lokhande, and Ravi Ramrathi Yadav. "Stability Indicating Method Development, Validation and Forced Degradation Study for Vilazodone Hydrochloride API." Oriental Journal Of Chemistry 37, no. 1 (2021): 204–12. http://dx.doi.org/10.13005/ojc/370128.

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The current study describes the short, stability indicative HPLC method development and successive validation of Assay and Related Substances methods for Vilazodone Hydrochloride API. This study also covers Vilazodone process impurities viz. Impurity A and Impurity B. The chromatographic conditions for Related Substances and Assay are similar except sample concentration. The proposed method utilizes C18 column (15 cm X 4.6 mm, 5 µ, make ZORBAX SB) and mobile phase having Methanol and 0.05 M KH2PO4 (55: 45 v/v). The separation between all three analytes was achieved in less than five minutes. T

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33

Vazquez, Raphaël, Romain Rotival, Sophie Calvez, et al. "Stability Indicating Assay Method on Vitamins: Application to their Stability Study in Parenteral Nutrition Admixtures." Chromatographia 69, no. 7-8 (2009): 629–35. http://dx.doi.org/10.1365/s10337-009-0979-1.

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34

Dedania, Zarna R., Ronak R. Dedania, Navin R. Sheth, Jigar B. Patel, and Bhavna Patel. "Stability Indicating HPLC Determination of Risperidone in Bulk Drug and Pharmaceutical Formulations." International Journal of Analytical Chemistry 2011 (2011): 1–6. http://dx.doi.org/10.1155/2011/124917.

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The objective of the current study was to develop a validated stability-indicating assay method (SIAM) for risperidone after subjecting it to forced decomposition under hydrolysis, oxidation, photolysis, and thermal stress conditions. The liquid chromatographic separation was achieved isocratically on a symmetry C18 column (5 μm size, 250 mm × 4.6 mm i.d.) using a mobile phase containing methanol: acetonitrile (80 : 20, v/v) at a flow rate of 1 mL/min and UV detection at 280 nm. Retention time of risperidone was found to be . The method was linear over the concentration range of 10–60 μg/mL wi

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35

Miss., Harshada Ravindra Patil, and Pavan Nathu Patil Mr. "Development and Validation of Stability Indicating Assay Method of Montelukast Tablet by RP-HPLC." International Journal of Trend in Scientific Research and Development 4, no. 1 (2019): 1039–46. https://doi.org/10.5281/zenodo.3609938.

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Background A simple, precise cost effective stability indicating assay method of Montelukast by RP HPLC. Material Chromatographic separation was achieved on a Meteoric core C18 column 100mm x 4.6 mm, 2.7Âµm using a mobile phase 2 ml Trifluroacetic acid mixture of acetonitrile 250ml and methanol 400ml 350 650 at a flow rate of 1.5ml per minute. Wavelength was detection at 255nm. The retention time of Montelukast was 4 minutes. Results The method was found linear concentration the range of 120.39 802.57Âµg ml, tablet analysis of RSD 0.403, accuracy range 30 , 50 , 100 , a

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36

Rathi, A. A., D. L. Dhamecha, M. H. G. Dehghan, et al. "Development and validation of a stability-indicating HPTLC assay method for idebenone." Acta Chromatographica 23, no. 2 (2011): 281–94. http://dx.doi.org/10.1556/achrom.23.2011.2.7.

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37

Trivedi, Piyush, C. Kartikeyan, Raman Kachave, and Rajendra Bhadane. "Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and its Metabolite." Journal of Liquid Chromatography & Related Technologies 32, no. 10 (2009): 1516–26. http://dx.doi.org/10.1080/10826070902901606.

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38

Saleh, Gamal A., Hassan F. Askal, Ibrahim H. Refaat, and Fatma A. M. Abdel-aal. "STABILITY INDICATING ASSAY AND KINETIC STUDY FOR NORFLOXACIN USING TLC-DENSITOMETRIC METHOD." Journal of Liquid Chromatography & Related Technologies 36, no. 4 (2013): 454–69. http://dx.doi.org/10.1080/10826076.2012.658591.

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39

Hanna, George M., and Cesar A. Lau-cam. "A Stability Indicating Proton NMR Spectroscopic Assay Method for Succinylcholine Chloride Injections." Analytical Letters 18, no. 17 (1985): 2183–94. http://dx.doi.org/10.1080/00032718508067980.

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40

Rivas-Granizo, Patricia, Silvia R. C. Jorge Santos, and Humberto G. Ferraz. "Development of a Stability-Indicating LC Assay Method for Determination of Chloroquine." Chromatographia 69, S2 (2009): 137–41. http://dx.doi.org/10.1365/s10337-009-0985-3.

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41

Wu, A. B., C. Y. Chen, S. D. Chu, Y. C. Tsai, and F. A. Chen. "Stability-Indicating High-Performance Liquid Chromatographic Assay Method and Photostability of Carprofen." Journal of Chromatographic Science 39, no. 1 (2001): 7–11. http://dx.doi.org/10.1093/chromsci/39.1.7.

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42

Sahoo, Pradyumna Kumar, Padmabhusana Sahoo, Jagannath Mohapatra, Debadash Panigrahi, Anup Kumar Patra, and Amiyakanta Mishra. "Development and Validation of Stability Indicating Assay Method of Doxycycline Hyclate by using UV-Spectrophotometer." Journal of Drug Delivery and Therapeutics 13, no. 6 (2023): 89–94. http://dx.doi.org/10.22270/jddt.v13i6.6087.

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In the present study a simple, rapid, sensitive, and cost-effective stability indicating UV- spectrophotometric method was developed of doxycycline hyclate in bulk form and validated as per ICH guidelines. The stability-indicating study of doxycycline hyclate was based on the forced degradation reactions of the drug under different ICH-prescribed stress conditions like acid, alkali, neutral, oxidation, thermal, and photolysis. The absorption maximum of the drug was shown at 270nm and methanol was selected as solvent on the basis of the solubility of the drug. A linear relation with a regressio

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43

Nimje, Hemlata M., and Meenakshi N. Deodhar. "STABILITY-INDICATING HPTLC METHOD FOR DETERMINATION OF DACLATASVIR IN PHARMACEUTICAL DOSAGE FORM." INDIAN DRUGS 58, no. 4 (2021): 56–62. http://dx.doi.org/10.53879/id.58.04.11662.

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A simple, specific, precise, and accurate stability-indicating assay method using high performance thinlayer chromatography (HPTLC) is described for estimation of daclatasvir dihydrochloride (DCV) in bulk drug and in the tablet dosage form. The separations were achieved on prepared TLC plates precoated with silica gel 60 F254. The mobile phase developed and optimized for bringing out the separation involves toluene: methanol in the ratio of (6:4 V/V). The densitometric scanning wavelength selected was 312.0 nm. The compact bands of DCV were obtained at RF value of 0.702±0.032. The method devel

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44

Brandalise, Mariana, Pamela Cristina Lukasewicz Ferreira, Andrea Garcia Pereira, Leonardo Meneghini, Pedro Eduardo Fröehlich, and Ana Maria Bergold. "STABILITY-INDICATING METHOD FOR DETERMINATION OF TIZANIDINE HYDROCHLORIDE IN PHARMACEUTICAL LC-CAD METHOD USING CHEMOMETRIC APPROACH." Drug Analytical Research 1, no. 1 (2017): 61–66. http://dx.doi.org/10.22456/2527-2616.75607.

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A new LC method for tizanidine hydrochloride in tablet dosage form using a charged aerosol detector (CAD) is described. The influence of various parameters on chromatographic system was investigated by factorial designs and Derringer's desirability. Chromatographic conditions were: mobile phase constituted of acetonitrile and ammonium acetate buffer 17 mM (60:40; v/v), column oven at 39 °C and flow rate 0.8 mL.min-1 performed in on Acclaim Trinity P1 column UV at 230 nm. Thus, it was possible to validate a simple method to assay the tizanidine and its counter-ion in three formulations (drug re

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45

Ajemni, Myriam, Issa-Bella Balde, Sofiane Kabiche, et al. "Stability-Indicating Assay for the Determination of Pentobarbital Sodium in Liquid Formulations." International Journal of Analytical Chemistry 2015 (2015): 1–6. http://dx.doi.org/10.1155/2015/697937.

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A stability-indicating assay by reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of pentobarbital sodium in oral formulations: a drug used for infant sedation in computed tomography (CT) or magnetic resonance imaging (MRI) scan. The chromatographic separation was achieved on a reversed-phase C18 column, using isocratic elution and a detector set at 214 nm. The optimized mobile phase consisted of a 0.01 M potassium buffer pH 3 and methanol (40 : 60, v/v). The flow rate was 1.0 mL/min and the run time of analysis was 5 min. The linearity

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Dunge, Ashenafi, Nishi Sharda, Baljinder Singh, and Saranjit Singh. "Establishment of inherent stability of stavudine and development of a validated stability-indicating HPLC assay method." Journal of Pharmaceutical and Biomedical Analysis 37, no. 5 (2005): 1115–19. http://dx.doi.org/10.1016/j.jpba.2004.09.014.

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Kulkarni, Pankaj N., C. K. Jadhav, A. S. Nipate, Alaknanda M. Dodake-Supekar, and C. H. Gill. "Stability Indicating RP-HPLC Method Development and Validation for Dexamethasone." Asian Journal of Chemistry 32, no. 3 (2020): 587–91. http://dx.doi.org/10.14233/ajchem.2020.22462.

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A new, simple, reliable and reproducible stability indicating RP-HPLC assay method has been developed for quantitative analysis of dexamethasone from dexamethasone tablets. This developed method has been validated according to ICH guideline with respect to system suitability, specificity, precision, linearity, accuracy and robustness. An isocratic condition of mobile phase water (0.1% orthophosphoric acid):acetonitrile in a ratio of 60:40, v/v at a flow rate of 1.0 mL/minute over RP 2.5 Fortis C18, 100 × 4.6 mm, 2.5 μm, column was at 27 ºC maintained. This method is specific and showed excelle

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Housheh, Samer, Daoud Ali, Saleh Trefi, Haroun Mohammad, and M. Fawaz Chehna. "Optimization of RP-HPLC Assay for Pharmaceutical Analysis of Clopidogrel." International Journal of Pharmaceutical Sciences and Nanotechnology 7, no. 1 (2014): 2371–76. http://dx.doi.org/10.37285/ijpsn.2014.7.1.9.

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An accurate, sensitive, precise and stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method for the analysis of clopidogrel bisulfate was developed and validated. The chromatographic conditions comprised of a reversible phase C18 column (250 × 4.6 mm, 5 μm) with a mobile phase consisting of a mixture of 50 mM potassium di-hydrogen phosphate and acetonitrile in the ratio of 75:25 at pH 3.0 adjusted with phosphoric acid. The flow rate was 1ml/min, the detection was carried out at 247 nm and the retention time of clopidogrel was 6.5 min. Clopidogrel was subjec

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Sversut, Rúbia Adrieli, Marcos Serrou do Amaral, Adriano César de Moraes Baroni, et al. "Stability-indicating HPLC-DAD method for the simultaneous determination of fluoroquinolones and corticosteroids in ophthalmic formulations." Anal. Methods 6, no. 7 (2014): 2125–33. http://dx.doi.org/10.1039/c3ay42031k.

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We develop and validate a stability-indicating assay method for simultaneous determination of gatifloxacin and prednisolone acetate, or of ciprofloxacin hydrochloride and dexamethasone in combination and in the presence of degradation products.

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Azhakesan, Ajitha, and Sujatha Kuppusamy. "QbD-Based Development and Validation of Novel Stability-Indicating Method for the Assay and Dissolution of Garenoxacin in Garenoxacin Tablets." Journal of AOAC INTERNATIONAL 105, no. 2 (2021): 370–78. http://dx.doi.org/10.1093/jaoacint/qsab157.

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Abstract Background Garenoxacin mesylate is a novel des-fluoro(6) quinolone, approved and marketed for human use in Japan under the name Geninax. Objective In this current work, a simple and stability-indicating method for the assay and dissolution of garenoxacin in garenoxacin tablets 200 mg was performed. New method developed for the particle size measurement of Garenoxacin mesylate Active Pharmaceutical Ingredient using Malvern 2000. Methods A quality by design (QbD)-based stability-indicating assay method was developed using 0.1% (v/v) formic acid in water and methanol (70:30). Using a pho

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