Author(s): Shailesh Koradia, Priyal Patel, Ashok Mahajan, Falgun Mehta, Abhijeetsinh Solanki

Email(s): shaileshkoradia.bip@bitseducampus.ac.in

DOI: 10.52711/0974-360X.2021.00793   

Address: Shailesh Koradia*, Priyal Patel, Ashok Mahajan, Falgun Mehta, Abhijeetsinh Solanki
Babaria Institute of Pharmacy, BITS Edu Campus, Vadodara, Gujarat, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 9,     Year - 2021


ABSTRACT:
In the present work, a precise, accurate and selective stability-indicating RP-HPLC method has been developed and validated according to International Conference on Harmonization guidelines Q2-(R1) for the simultaneous quantitative determination of Tolterodine tartrate and Tamsulosin hydrochloride in bulk and its capsule formulation. The chromatographic separation was achieved on Hypersil octadecyl silane C18 (250 x 4.6mm, 5 µm) column at room temperature and mobile phase comprised of methanol: 0.05 M phosphate buffer, pH 7.0 in the ratio of 90:10 V/V. The flow rate of mobile phase was set at 1.0mL/min and compounds were monitored at 255nm using photodiode array detector. Tamsulosin hydrochloride and Tolterodine tartrate retention time were found to be 4.15±0.2 min and 8.42±0.2 min, respectively. The drug substances and products were subjected to acid hydrolysis, alkali hydrolysis, oxidative hydrolysis, photolytic and thermal degradation. The percent degradation of drugs was calculated in all stressed conditions. The analytical method validation parameters such as linearity, accuracy, precision, detection limits, quantitation limits and robustness indicate that drug substances and products were efficiently separated in present of their degradants and successfully applied for the routine analysis of Tolterodine tartrate and Tamsulosin hydrochloride in bulk and its capsule formulation in the quality control laboratory.


Cite this article:
Shailesh Koradia, Priyal Patel, Ashok Mahajan, Falgun Mehta, Abhijeetsinh Solanki. Separation and Simultaneous Quantitation of Tolterodine Tartrate and Tamsulosin Hydrochloride in Capsule Formulation by using Stability-Indicating RP-HPLC-DAD Method. Research Journal of Pharmacy and Technology. 2021; 14(9):4561-6. doi: 10.52711/0974-360X.2021.00793

Cite(Electronic):
Shailesh Koradia, Priyal Patel, Ashok Mahajan, Falgun Mehta, Abhijeetsinh Solanki. Separation and Simultaneous Quantitation of Tolterodine Tartrate and Tamsulosin Hydrochloride in Capsule Formulation by using Stability-Indicating RP-HPLC-DAD Method. Research Journal of Pharmacy and Technology. 2021; 14(9):4561-6. doi: 10.52711/0974-360X.2021.00793   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-9-7


REFERENCES:
1.    Tripathi K. D., Editors. Essentials of Medical Pharmacology, Jaypee Brothers Publishers Ltd, New Delhi, 2003, 6th ed., pp. 135-136.
2.    Indian Pharmacopoeia. Govt. of India Vol-III. Ghaziabad: Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission. 2007; pp. 2891-2892.
3.    British Pharmacopoeia; London, British Pharmacopoeia Commission, 2016, 8th ed; pp 1082-1084.
4.    Shetty SK, Shah K. New spectrophotometric method for estimation of Tolterodine in bulk and pharmaceutical formulation. International Journal of Pharmaceutical Sciences and Research. 2011; 2(6): 145514-61.
5.    Bari SB, et Al. Application of UV-spectroscopy and first order derivative method for determination of tamsulosin hydrochloride in bulk and tablets. Pharmaceutica Analytica Acta. 2011; 2(2): 11-16.
6.    Rani GD, at Al. Development and Validation of Ultraviolet-Spectrophotometric Method for the Determination of Tamsulosin. Indian Journal of Advances in Chemical Science. 2015; 3(4): 323-327.
7.    Jadhav RS, Bharad JV. Analytical Method Development and Validation for Estimation of Tamsulosin Hydrochloride by UV-Spectroscopic method.  International journal of chem tech Research. 2017; 10(5): 740-747.
8.    Nanda, RK, et Al. Estimation of Tamsulosin and Tolterodine in its pharmaceutical dosage form by Spectrophotometric method. International journal of chemtech Research. 2009; 1(3): 420-423.
9.    Viplava U, et Al. Assay of Tolterodine Tartrate in Bulk and Capsule Formulations by using Simple and Affordable Visible Spectrophotometric Methods. Research Journal of Pharmaceutical Dosage Forms and Technology. 2012; 4(4): 211-215.
10.    Prajakta D, et Al. Implementation UV-Spectrophotometry approach for Determination of Tamsulosin HCl in tablets using area under Curve Technique. Asian Journal of pharmaceutical Analysis. 2020; 10(2): 86-90.
11.    Susmitha K., et Al. Extractive Spectrophotometric Methods for Determination of Tamsulosin HCl in Pharmaceutical Formulations Using Acidic Triphenyl Methane Dyes. Asian Journal of Research in Chemistry.2011: 4(7): 1114-1118.
12.    Mohammed WN, et Al. Spectrofluorimetric determination of tolterodine tartarate in pure form and pharmaceutical preparation. International Journal of Pharmaceutical Science and Research. 2013; 4(10): 3845-3849.
13.    Shetty SK, Shah K. Development and validation of tolterodine by RP-HPLC method in bulk drug and pharmaceutical dosage forms. International Journal of Pharmaceutical Research. 2011; 3: 1083-1087.
14.    Saxena V, et Al. Stability indicating HPLC determination of tolterodine tartrate in pharmaceutical dosage form. Indian Journal of Chemical Technology. 2006; 13: 242-246.
15.    Shah U, et Al. Stability Indicating RP-HPLC Method Development and Validation of Tolterodine Tartrate and its Degradants in its Capsule Dosage Form. Journal of Pharmaceutical Science and Research. 2017; 9(6): 860-866.
16.    Laha TK, et Al. RP-HPLC Method for the Determination of Tamsulosin in Bulk and Pharmaceutical Dosage Forms. Asian Journal of Chemistry. 2011; 23(1): 11-14.
17.    Mhamunkar SM, et Al. RP-HPLC method development and validation for the simultaneous estimation of Tamsulosin HCl and Tolterodine tartrate in pharmaceutical dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2012; 4(5): 319-322.
18.    Nanda RK, et Al. Simultaneous RP-HPLC estimation of Tamsulosin and Tolterodine in its pharmaceutical dosage form. Journal of Pharmacy Research. 2009; 2(11): 1786-1788.
19.    S. Ashutosh Kumar, et Al. Stability Indicating RP-HPLC Method for the Determination of Tolterodine Tartrate in Bulk as well as in Pharmaceutical Formulation. Asian Journal of Research in Chemistry. 2013: 6(7): 694-701.
20.    Joshi HV, et Al. Development and Validation of Stability Indicating Method for the Simultaneous Estimation of Tamsulosin HCl and Tolterodine Tartrate in Pharmaceutical Dosage form. Asian Journal of Pharmaceutical Analysis. 2019; 9(4): 205-209.
21.    Nidhi K. Patel, Shailesh K. Koradia. Development and Validation of stability indicating RP-HPLC method for the simultaneous estimation of Beclomethasone dipropionate and Formoterol fumarate in their combined pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2016; 6(2): 83-90.
22.    SS Chitlange, et Al. Stability Indicating RP- HPLC Method for Simultaneous Estimation of Valsartan and Amlodipine in Capsule Formulation. Asian Journal of Research in Chemistry. 2008; 1(1): 15-18.
23.    Deepa R. Patel, et Al. Stability Indicating HPLC Method for Simultaneous Determination of Repaglinide and Metformin Hydrochloride in Pharmaceutical Dosage Form. Asian Journal of Research in Chemistry. 2011; 4(3): 500-505.
24.    Kinjal V. Vekariya, et Al. Development and Validation of Stability Indicating RP-HPLC method for simultaneous estimation of Thiocholchicoside and Lornoxicam in Combined Tablet Dosage Form. Asian Journal of Research in Chemistry. 2012; 5(8): 980-984.
25.    Mohammed EA, et Al. A Validated LC-MS/MS Method for the Determination of Tamsulosin Hydrochloride in Six Brands; Applications to Content Uniformity and Dissolution Studies. Reseach Journal of Pharmacy and Technology. 2011; 4(12): 1885-1890.
26.    Mishra A, et Al. Stability-indicating HPTLC method for analysis of Tolterodine in the bulk drug. Journal of Planner Chromatography. 2011; 24(2): 150-153.
27.    Shah A, et Al. Simultaneous estimation of Tolterodine tartrate and Tamsulosin HCl by validated HPTLC assay method from combination capsule form. Journal of Chemical  and Pharmaceutical Research. 2015; 7(5): 81-88.
28.     ICH Harmonized Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology, Q2(R1); International Conference on Harmonization, IFPMA, Geneva, Switzerland. 2005.

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