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Journal articles on the topic 'Stability indicating assay method'

Author: Grafiati

Published: 5 June 2025

Last updated: 25 June 2025

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1

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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2

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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3

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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4

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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5

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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6

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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7

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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8

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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9

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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10

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 determination in 25–1400 ng/band range with a determination coefficient of 0.9974. The suggested analytical assay for FFA analysis was simple, rapid, accurate, precise, robust, selective, stability-indicating, and greener. The AGREE scale for the developed stability-indicating HPTLC assay was derived to be 0.77 utilizing AGREE methodology, indicating an outstanding greenness characteristic of the suggested densitometry technique. The ecofriendly HPTLC technique was able to detect FFA degradation product under forced degradation studies, indicating its stability-indication characteristics and selectivity. The amount of FFA in marketed tablets brand A and B was determined to be 101.28 and 99.17%, respectively, indicating the suitability of the suggested analytical technique in the assay of FFA in marketed products. These results indicated that FFA in marketed products may be routinely measured using the stability-indicating greener HPTLC technique.

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11

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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12

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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13

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 determination of LC along with lumiflavin (LF) by a two-component spectrometric method at 356 and 445 nm. The method has been validated and the results of the assay of RF in photodegraded solutions compare well with those of the standard USP fluorimetric method. The recovery of the method is 99–101% and the precision is within 2%. The method is stability-indicating and can be applied to the assay of RF in photodegraded solutions and aged vitamin preparations. The method is specific compared to that of the USP fluorimetric method in which the degraded LC may interfere with the fluorescence emission of RF.

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14

Jaya, P. Ambhore, S. Adhao Vaibhav, S. Cheke Rameshwar, R. Popat Ritesh, and J. Gandhi Shital. "Futuristic review on progress in force degradation studies and stability indicating assay method for some antiviral drugs." GSC Biological and Pharmaceutical Sciences 16, no. 1 (2021): 133–49. https://doi.org/10.5281/zenodo.5168617.

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Force degradation studies of drug substance give perceptive knowledge about the intrinsic stability of the molecule as well as possible degradants which formed during the shelf life of drug and thus, aid within the successive development of its stable formulation. A number of analytical methods with hyphenated techniques are required for the identification, determination and characterization of degraded product and impurities produce during different conditions of stress studies; Chromatographic methodology play a vital role in the field of impurity and degradation profiling .This review summarizes the current regulatory requirements guidelines for the laboratory performance of forced degradation and its application for the development of stability indicating method. There are number of strategies have been implemented for the quantitative assessment of antiviral drugs. This study will provide detailed literature on stability- indicating HPLC/ RP-HPLC approaches for the development and validation of various antiviral drugs.

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15

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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16

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 formed under stress conditions was achieved on a phenomenex Gemini column with potassium dihydrogen phosphate buffer, pH adjusted to 2.2 with orthophosphoric acid, as mobile phase. The method was validated for linearity, precision, specificity and robustness and can be used for quality-control during manufacture and assessment of the stability of samples of silver lactate. To the best of our knowledge, a validated stability-indicating LC assay method for silver lactate based on lactic acid is reported for the first time.

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17

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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18

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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19

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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20

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 and concentration covering concentrations from 100 to 700 ng applied to the spot. The method was validated to check if it was accurate, precise, linear, and robust following the International Council for Harmonization guidelines. Detection and quantitation limit of the method also were determined. Empagliflozin was further subjected to forced degradation followed by analysis using the proposed method on the samples. The analytical method enabled precise, selective, and accurate analysis of Empagliflozin when its degradation products were present. The method developed can be used to quantitatively analyze Empagliflozin in bulk drug, formulations, and stability studies.

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21

Alam, Prawez, Faiyaz Shakeel, Wael A. Mahdi, et al. "Determination of Gefitinib Using Routine and Greener Stability-Indicating HPTLC Methods: A Comparative Evaluation of Validation Parameters." Processes 10, no. 4 (2022): 762. http://dx.doi.org/10.3390/pr10040762.

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“High-performance thin-layer chromatography (HPTLC)” methods for gefitinib (GFT) estimation are scarce in the literature. In addition, greener analytical techniques for GFT estimation are also lacking in the literature. Accordingly, an attempt was undertaken to invent and validate a sensitive and greener normal-phase HPTLC method for GFT analysis in commercial tablets in comparison to the routine normal-phase HPTLC method. The greenness index for both methods was assessed using “Analytical GREENness (AGREE)” methodology. GFT detection was carried out using both methods at 332.0 nm. In the 30–700 ng/band and 20–1400 ng/band ranges, the routine and greener HPTLC assays were linear for GFT estimation. The greener HPTLC method was highly sensitive, more accurate, more precise, and more robust than the routine HPTLC assay for GFT estimation. Both methods were able to detect GFT in the presence of its degradation products, suggesting the stability-indicating property of both methods. The assay of GFT in commercial tablets was 92.45% and 99.74% using the routine and greener HPTLC assays, respectively. The AGREE index for routine and greener analytical assays was predicted to be 0.44 and 0.77, respectively, indicating the excellent greenness index of the greener HPTLC assay over the routine HPTLC assay. The greener HPTLC assay is considered superior to the routine HPTLC assay based on these results.

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22

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 conditions. Mild degradation of the drug substance was observed during acidic hydrolysis and no degradation was observed during basic hydrolysis.

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23

Upadhyay, Priya Shitalaprasad* Dr Vinay C. Darji Bhumi Patel Jaymin Patel. "DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR ESTIMATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 3209–19. https://doi.org/10.5281/zenodo.1240480.

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A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for Teriflunomide In its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Teriflunomide in its Pharmaceutical Dosage Form has been developed. The separation was achieved by Cosmosil (250mm x 4.6 mm) column and Buffer (pH 4.0): Methanol (40:60) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 248 nm. Retention time of Teriflunomide was found to be 3.300 min. The method has been validated for linearity, accuracy and precision. Linearity observed for Teriflunomide 10-30 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Teriflunomide in its Combined Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in Thermal degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form. Keywords: Teriflunomide, Stability indicating RP-HPLC Method, Validation.

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24

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 technology was derived using the “Analytical GREENness (AGREE)” approach. The proposed stability-indicating HPTLC assay was linear for CDN analysis in the 50-1000 ng/band range with a determination coefficient of 0.9978. The proposed analytical technique for CDN analysis was simple, rapid, accurate, precise, robust, selective, stability-indicating, and greener. The AGREE score for the proposed stability-indicating HPTLC technique was calculated to be 0.79 using the AGREE calculator. The current protocol was able to detect CDN degradation products under various stress conditions, indicating its stability-indication characteristics and selectivity. The AGREE quantitative score indicated that the stability-indicating current protocol had outstanding greener characteristics. The amount of CDN in the laboratory-developed formulation was determined to be 98.84%, indicating the suitability of the current protocol in the assay of CDN in the formulations. These results suggested that CDN in a laboratory-developed formulation may be regularly determined using the stability-indicating greener HPTLC strategy.

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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 count, and symmetry factor. Chromatography was performed on a Symmetry C18 column with a mobile phase of 0.01N potassium dihydrogen phosphate and acetonitrile (57.4:42.6% v/v), at a flow rate of 1.11 mL/min, detection at 220 nm, and column temperature of 30°C. Posaconazole’s retention time was 3.663 minutes, with precise, accurate, and linear signals (R² = 0.999). The method is simple, fast, cost-effective, and ideal for routine quality control.

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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 spectrophotometric method at 370 nm. It exhibits a high intensity of absorption in the UV region that can be used for the assay of even low concentrations of TH. Under optimum conditions, Beer’s law is obeyed in the concentration range of 0.20–2.00 mg/100 ml (R2 = 09998). The limit of detection (LOD) and limit of quantification (LOQ) are 0.0076 and 0.0231 mg/100 ml, respectively. The method has been validated and applied to aqueous solutions and vitamin preparations. The results have statistically been compared with the United States Pharmacopeia liquid chromatography method. It has been found that there is no significant difference between the two methods at 95% confidence level.

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30

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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31

R., Sairam Aditya, Tengli Anandkumar, Ramesha, S. Chandan R., Anupama K., and M. Gurupadayya B. "Development and Validation of Stability Indicating UFLC Method for the Estimation of Anti-spasmodic Drug - Valethamate Bromide." Journal of Advances in Medical and Pharmaceutical Sciences 13, no. 3 (2017): 1–12. https://doi.org/10.9734/JAMPS/2017/26825.

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A stability indicating Ultra-Fast Liquid Chromatography (UFLC) method has been developed to estimate valethamate bromide (V&B) in tablet dosage forms and to separate analyte from other degradants and to carryout forced degradation studies. The chromatographic separation was achieved by using phenomenex kinetex 5 μ C<sub>18</sub> 100A (250x 4.6 mm) column with a flow rate of 1 mL/min in an isocratic mode with the mobile phase consisting of 0.05 M potassium dihydrogen phosphate buffer pH 7.5 (adjusted with potassium hydroxide) and acetonitrile in the ratio of 50:50. The eluents were monitored with PDA detector at 227 nm. In this developed method valethamate bromide was eluted at a retention time of 4.4 ± 0.1 min. The proposed method is having linearity in the concentration range of 2-12 μg/mL. The present method was successfully validated with respect to system suitability, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per international council for harmonization (ICH) guidelines. The drug was subjected to different degradation conditions like acid and alkali hydrolysis, oxidation, thermal and UV radiation etc. Peak purity of the drug was passed in all degradation conditions which demonstrated the specificity of assay method for it in presence of degradation products. The proposed method can be applied for determination of valethamate bromide in pure drug and in pharmaceutical formulation.

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32

Mohammad, Mujeeb Gulzar Khan, and Arun Shirkhedkar Atul. "Validated Stability-indicating NP-HPTLC/Densitometry Method for the Assay of Zolpidem Tartrate in Pharmaceutical Dosage Form." Pharmaceutical Methods 8, no. 2 (2017): 87–91. https://doi.org/10.5281/zenodo.14856315.

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Background: A simple, precise stability-indicating Normal- Phase Thin-Layer Chromatography (NP- TLC)/ Densitometry method has been studied for estimation of zolpidem tartrate in bulk and in tablet formulation. Method: The chromatographic separation was accomplished on aluminium backed precoated silica gel 60 F254S as the stationary phase using Ethyl acetate: Methanol: triethylamine (9: 1: 0.3 v/v) as mobile phase. Densitometric analysis of zolpidem tartrate was achieved at λ max 293 nm. The method was validated for robustness, precision and accuracy. Stress degradation of zolpidem tartrate was carried out under various reaction conditions including acid, base, oxidation, photo-degradation and dry heating treatment. Result: This system was found to give compact spot for zolpidem tartrate at Rf value 0.56 ± 0.02. The data of linear regression analysis of zolpidem tartrate indicated a good linear relationship over the range of 300 – 1800. LOD and LOQ found 18.10 and 54.84 ng. Resulted stress drugs were analyzed with the developed TLC/ densitometry method. Conclusion: Statistical analysis proves that the method is repeatable and selective for the estimation of zolpidem tartrate in bulk and in formulation. As the method could effectively separate the drug from its degradation products, it can be employed as a stability- indicating method.

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33

Jabeen*, Md. Akram Abdul Sayeed. "METHOD DEVELOPMENT, VALIDATION AND STABILITY INDICATING ASSAY PROCEDURE OF PREGABALIN BY USING RP-HPLC." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 03 (2018): 1936–54. https://doi.org/10.5281/zenodo.1212443.

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A simple, rapid and precise Reverse phase liquid chromatographic method has been developed and subsequently validated for estimation of Pregabalin in tablet dosage form. The method is based on High Performance Liquid Chromatography (HPLC) on a reversed-phase column. The separation was carried out using a mobile phase consisting of Phosphate buffer of pH 6.2 and acetonitrile (70:30 v/v). The column used was reversed-phase, Develosil C18, (5µm, 150 x 4.6 mm i.d. column) with flow rate of 1.0 ml/min, column temperature at 40°C using UV detection at 225 nm. The drug was well resolved on the stationary phase and the retention times were around 2.33 minute. The method was validated and shown to be linear for Pregabalin. The correlation coefficient for Pregabalin is 0.998. The relative standard deviations for five replicate measurements in two sets of each drug in the tablets is always less than 2% and mean % error of active recovery not more than ±1.5%. Pregabalin was subjected to various degradation conditions like acidic, alkaline, thermal, oxidation, photo, UV degradation and neutral conditions for a period of 24 hrs and it was found to degrade to different extent in different conditions. Pregabalin was found to be highly degraded at oxidation and photo degradation and comparatively stable under neutral condition. The method was validated for precision and accuracy. The proposed method was successfully applied to the pharmaceutical dosage forms containing the above mentioned drug without any interference by the excipients. Keywords: Pregabalin and RP- HPLC method.

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Bakshi, Monika, and Saranjit Singh. "Development of validated stability-indicating assay methods—critical review." Journal of Pharmaceutical and Biomedical Analysis 28, no. 6 (2002): 1011–40. http://dx.doi.org/10.1016/s0731-7085(02)00047-x.

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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 less than 1.0%. Accuracy of the method ranged from 98.6 to 101.5% with RSD < 0.6%. Specificity of the assay showed no interference from tablets components and breakdown products formed by alkaline, acidic, oxidative, sunlight, and high temperature conditions. This method allows accurate and reliable determination of idebenone for drug stability assay in pharmaceutical studies.

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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 with forced degradation studies as per ICH guidelines.Results: Prepared batches were evaluated for all pre-compression parameters and post-compression parameters. Formulation batch F5 prepared by direct compression shows highest dissolution release of 90.97 % over the period of 60 min while disintegration time was found to be 136 seconds. The retention time of developed HPLC method was found to be 5.66 min. This method was found to be linear in a concentration range of 5-30 μg/ml of the drug (r2= 0.999). The low value of % RSD in the precision study indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The results of forced degradation studies indicated that the drug was less stable in thermal and photolytic condition and degraded in acidic, basic, oxidative conditions.Conclusion: On the basis of formulation evaluation, batch F5 was found to be promising formulation suitable for the immediate release of apixaban. Results obtained by validation studies suggested that the developed stability indicating assay method is simple, accurate, specific, sensitive and precise. Thus, this method can be used for routine analysis of apixaban formulation and to check the stability testing.

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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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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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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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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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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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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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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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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. The analytical validation of these method was carried out successfully as per ICH and other international guidelines. The API was subject to various stress conditions like temperature, humidity, acidic and basic hydrolysis, oxidative degradation. The exposed samples analysed for impurities and assay. The mass balance for each condition was found more than 98%.

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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 , and 200 , Precision RSD 0.3. The proposed method was validated as per the ICH guidelines. Conclusion The HPLC method was validated and demonstrated good linearity, precision, accuracy, specificity, robustness and stability indicating. The development HPLC method can be utilized for routine analysis stability studies for Montelukast. Miss. Harshada Ravindra Patil | Mr. Pavan Nathu Patil "Development and Validation of Stability Indicating Assay Method of Montelukast Tablet by RP-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-1 , December 2019, URL: https://www.ijtsrd.com/papers/ijtsrd29809.pdf

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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 developed was able to separate peaks of all the degradation products formed in ICH prescribed stress conditions with sufficient difference in their RF values. The developed method was validated for linearity and range, specificity, precision, accuracy, and robustness, and the results were found to be within acceptance criteria. The reliability of the method was evaluated when it was applied for the estimation of DCV in pharmaceutical tablet formulation and assay results gave good recovery.

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Chandan, Nakum*¬ Harpal Makwana Vaishali Karkhanis Hina Bagada. "Stability Indicating Assay Method Development and Validation of HPTLC Method for Estimation of Prochlorperazine maleate in Bulk and Tablet Dosage Form." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 1957–72. https://doi.org/10.5281/zenodo.15057985.

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Prochlorperazine maleate is an Antiemetic and Antipsychotic Tranquilizer. It is used for the treatment of severe nausea and vomiting, as well as short-term management of psychotic disorders such as generalized non-psychotic anxiety and schizophrenia. An extensive literature surveys reveals that various analytical methods have been reported for the estimation of Prochlorperazine maleate in API and pharmaceutical dosage form. So, it was thought to develop simple, precise, accurate and specific stability indicating HPTLC method for the estimation of Prochlorperazine maleate in API & pharmaceutical dosage form and validate the developed method for different parameters like accuracy, precision, linearity, robustness etc., as per ICH guidelines. HPTLC method was developed using mobile phase Methanol: n-butanol: triethylamine (9:0.9:0.1 v/v/v). In HPTLC method linearity was found to be with in range 200-1000 ng/band, the correlation coefficient was found to be 0.9991. The LOD and LOQ was found to be 35.48ng/band & 107.53ng/band respectively. Forced degradation study was carried out using acidic, basic, oxidative, thermal and photolytic condition. HPTLC method was found to be simple, accurate, and precise according to acceptance criteria given in ICH guideline.

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Carlota, Rosita Ruth, Anjali Nayak, Yashwanth V. Reddy, K. R. Prathibha, T. Nirma, and Daphisha Marbaniang. "RP HPLC-Based Method Development, Validation and Stability Indicating Assay of Levosulpiride in Bulk Drug Using Analytical Quality by Design Approach." Indian Journal Of Science And Technology 16, no. 46 (2023): 4436–44. http://dx.doi.org/10.17485/ijst/v16i46.2995.

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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 reference, generic and manipulated). Method showed specificity when challenged by forced degradation and excipients. Finally, the method was compared with USP monograph method demonstrating equivalence in assay evaluation.

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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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