QBD approach to develop stability indicating RP-HPLC method development for Levosulpiride and Ilaprazole
Keywords:
Levosulpiride, Ilaprazole, QbD, RP-HPLC, Stability Study, method development, validationAbstract
Objectives: As per requisition of current regulatory requirements, simple, rapid and sensitive method by 33 factorial QbD approach was established and validated for Levosulpiride and Ilaprazole by RP-HPLC. Method: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, LOD, LOQ, accuracy as per ICH guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Auto injector, UV (DAD) & Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C18 column (4.6mm x 250mm; 5µm), a 20µl injection loop and UV730D Absorbance detector at 219 nm wave length and running chemstation 10.1 software and drugs along with degradants were separated via Methanol: (0.1% OPA) Water (45:55) of pH 3.2 as mobile phase setting flow rate 0.6 ml/min at ambient temperature, retention time at 4.257 min and 5.547 min. with good peak shape (Theoretical plates of 6972 of Levosulpiride and 3521 of Ilaprazole). The LOD and LOQ of Levosulpiride were found to be 1.8208μg/ml and 5.5176μg/ml. The LOD and LOQ of Ilaprazole were found to be 0.3676μg/ml and 1.1139 μg/ml analytical method that concluded.
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Avhad, P. S., & Gupta, R. (2022). RP-HPLC analytical method development and validation of obeticholic acid in bulk and marketed formulation. International Journal of Health Sciences, 6(S6), 593–600. https://doi.org/10.53730/ijhs.v6nS6.9648
Elder, D. P., & Borman, P. (2013). Improving analytical method reliability across the entire product lifecycle using QbD approaches. Pharmaceutical Outsourcing, 14(4), 14-19.
Gaikwad, N. M., Chaudhari, P. D., & Shaikh, K. S. (2022). Gradient RP-HPLC method development and validation for simultaneous estimation of paclitaxel and albendazole. International Journal of Health Sciences, 6(S3), 6595–6605. https://doi.org/10.53730/ijhs.v6nS3.7471
Ilaprazole, Pubchem, U.S. National Library of Medicine, 2005; CID- 214351.
Jain, N., Raghuwanshi, R., & Jain, D. (2008). Development and validation of RP-HPLC method for simultaneous estimation of atorvastatin calcium and fenofibrate in tablet dosage forms. Indian Journal of Pharmaceutical Sciences, 70(2), 263.
Kaur, N. (2021). Biochemical and HPLC analysis of apple juice. International Journal of Health Sciences, 5(S1), 387–398. https://doi.org/10.53730/ijhs.v5nS1.5674
Khimani, R., & Kapupara, P. (2018). Development and Validation of HPLC Method for determination of Ilaprazole and Levosulpride. Research Journal of Pharmacy and Technology, 11(4), 1491-1495.
Kumar, R., Singh, S., Kamal, S. S., Kaur, D., Singh, M., & Katual, M. K. (2017). Development and Validation of Spectrophotometric Method for Estimation of Levosulpiride in Bulk and Tablet Dosage Form. Eurasian Journal of Analytical Chemistry, 12(3), 265-273.
Levosulpiride, Pubchem, U.S. National Library of Medicine, 2005; CID- 688272.
Pannu, S., Thakur, M., Gulati, P., Kumar, M., Dhingra, D., & Pannu, A. (2022). A recent review on developed analytical methods for detection of curcumin. International Journal of Health Sciences, 6(S7), 173–194. https://doi.org/10.53730/ijhs.v6n7.10807
Patel, M. N., & Kothari, C. S. (2016). Multivariate approaches for simultaneous determination of avanafil and dapoxetine by UV chemometrics and HPLC-QbD in binary mixtures and pharmaceutical product. Journal of AOAC International, 99(3), 649-663.
Pawar, S. S., Deshmukh, D. D., Gorde, P. L., & Gosavi, S. A. (2022). Development and validation of RP – HPLC method for quantitation of luliconazole in bulk and formulation. International Journal of Health Sciences, 6(S2), 14944–14952. https://doi.org/10.53730/ijhs.v6nS2.8962
Raman, N. V. V. S. S., Mallu, U. R., & Bapatu, H. R. (2015). Analytical quality by design approach to test method development and validation in drug substance manufacturing. Journal of chemistry, 2015: 1-8.
Rami, D. H., & Patel, S. K. (2018). Simultaneous Estimation of Levosulpiride and Ilaprazole in Capsule Dosage Form by Simultaneous Equation Spectrophotometric Method and Q-Absorbance Ratio Method. World J. Pharm. Res, 7, 1986-1995.
S.Surve, J. Patel, Arpit Patwari, Mahesh Chhabaria, (2013). HPTLC and HPLC method development and validation for simultaneous estimation of rabeprazole sodium and levosulpiride in bulk and its pharmaceutical dosage form. Int J Pharm Pharm Sci, 5(3), 65-9.
Sharma B.K. (2005), Instrumental Methods of Chemical Analysis, 20th edition, GOEL Publishing House, pp 68-80.
Sharma, B. K. (1981). Instrumental methods of chemical analysis. Krishna Prakashan Media. 71-110.
Shelke, P. G., Chandewar, A. V., Dewani, A. P., Tripathi, A. S., & Bakal, R. L. (2015). Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography. Eurasian Journal of Analytical Chemistry, 10(1).,1-9.
Shetty, P. R., & Patil, D. D. (2014). Applications of simultaneous equation method and derivative method for the determination of rabeprazole sodium and levosulpiride in pharmaceutical dosage form and dissolution samples. Journal of the Association of Arab Universities for Basic and Applied Sciences, 15(1), 53-60.
Silambarasan, S. P., Anandakumar, K., Venkatalakshmi, R., & Sasikala, C. (2010). Development of UV Spectrophotometry and RP-HPLC Methods for the Estimation of Levosulpiride in Bulk and in Tablet Formulation. Asian j res chem, 3(3), 542.
Tamboli, R., Chauhan, V., Pathan, M., Tirgar, S., Shah, D., & Parmar, R. (2014). Development and validation of Rp-Hplc method for simultaneous estimation of ilaprazole and domperidone in pharmaceutical dosage form. PharmaTutor, 2(7), 149-156.
Tol, T., Kadam, N., Raotole, N., Desai, A., & Samanta, G. (2016). A simultaneous determination of related substances by high performance liquid chromatography in a drug product using quality by design approach. Journal of Chromatography A, 1432, 26-38.
Tol, T., Tawde, H., Gorad, S., Jagdale, A., Kulkarni, A., Kasbale, A., ... & Samanta, G. (2020). Optimization of a liquid chromatography method for the analysis of related substances in daclatasvir tablets using design of experiments integrated with the steepest ascent method and Monte Carlo simulation. Journal of Pharmaceutical and Biomedical Analysis, 178, 112943.
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