The QUALITY BY DESIGN APPROACH FOR SIMULTANEOUS DETERMINATION OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
Keywords:Gradient, ICH, UPLC, QbD and Validation
Objective: To develop and validate a novel and simple reverse phase Ultra Performance Liquid Chromatography (UPLC) method for simultaneous determination of Fluticasone Propionate and Salmeterol Xinafoate from pharmaceutical finished product, applying Quality by design (QbD) approach.
Methods: The proposed analytical method developed and validated in a linear gradient condition at a flow rate of 0.40 ml/min over Waters ACQUITY BEH Shield RP 18, 2.1*100 mm, 1.7 µm column by maintaining column oven temperature at 30 °C and Sample cooler temperature at 15 °C. Chromatograms monitored and recorded at 215 nm.
Results: The proposed method has been validated as per International Conference on Harmonization (ICH) guidelines with respect to system suitability, specificity, precision, linearity, accuracy, range, solution stability and robustness. This method is qualified in all parameters in case of system suitability and specificity; precision observed within the limit of 2.0%, the excellent linear response observed with correlation coefficient (R2) for Salmeterol 0.99999 and Fluticasone Propionate 0.99999, for Accuracy within the limit of 98% to 102%.
Conclusion: A selective, suitable and accurate reverse phase UPLC method for simultaneous Determination of Fluticasone Propionate and Salmeterol Xinafoate in the pharmaceutical finished product has been developed and validated successfully.
https://emedicine.medscape.com/article/296301-overview. [Last accessed on 10 Feb 2020]
Gill CH, Kulkarni PN, Nipte AS, Jadhav CK, Chate AV, Dodake Supekar AM. A study of method development and validation for estimation of Azelastine hydrochloride in nasal spray formulations by RP-HPLC method. J Drug Delivery Ther 2018;8:236-40.
https://www.rxwiki.com/fluticasone-propionate. [Last accessed on 10 Feb 2020]
https://en.wikipedia.org/wiki/Salmeterol. [Last accessed on 10 Feb 2020]
http://www.uspbpep.com/usp29/v29240/usp29nf24s0_m34220.html [Last accessed on 10 Feb 2020]
https://www.drugfuture.com/pharmacopoeia/usp35/data/v35300/usp35nf30s0_m74389.html [Last accessed on 10 Feb 2020]
Andre R, Sa COUTO, Daniela Espinha CARDOSO, Helena Maria CABRAL-MARQUES. Validation of an HPLC analytical method for the quantitative/qualitative determination of fluticasone propionate in inhalation particles on several matrices. Sci Pharm 2014;82:787-97.
Ahmed S, Hesham S, Mohammad A, New developed spectroscopic method for simultaneous determination of salmeterol xinafoate and fluticasone propionate in bulk powder and seritide discus inhalation. Bull Fac Pharm (Cairo Univ) 2012;50:121-6.
Jain PS, Gorle AP, Patil SS, Chavan RS, Bari PR, Surana SJ. Stability-indicating RP-HPLC method for estimation of salmeterol xinafoate in bulk and in pharmaceutical formulation. Int J Pharm Chem Anal 2015;2:28-33.
Shahanaz M, Vageesh NM, Nizamuddin ND, Hazra BB. Development and validation of an RP-HPLC PDA method for simultaneous determination of fluticasone and salmeterol in bulk and pharmaceutical dosage form. Innovat Int J Med Pharm Sci 2018;3:25-8.
Nayak VG, Belapure SG, Gaitonde CD, Sule AA. Determination of salmeterol in metered-dose and dry-powder inhalers by reversed-phase high-performance liquid chromatography. J Pharm Biomed Anal 1996;14:511-3.
Prathap B, Jegannath S, Swathikrishna K, Priyanka V, Rajeshwari G, Gobalakrishnan P. Method development and validation for simultaneous estimation of azelastine and fluticasone in pharmaceutical dosage form by RP-HPLC. Asian J Pharm Anal Med Chem 2016;4:79-87.
International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. Pharmaceutical development Q8 (R2); 2009.
International Conference on Harmonization, Guideline on Validation of Analytical Procedure: Text and Methodology, Q2 (R1); 2005.
Lloyd R Snyder, Joseph J Kirkland, Joseph L Glajch. 2nd ed. Practical HPLC method development; 1997.
Desai N, Momin M, Singh U, Khan T, Sherje A. Analytical method development and validation for simultaneous estimation of curcumin and cyclosporine by RP-HPLC. Int J Pharm Pharm Sci 2018;11:26-33.
SADC Guideline for stability testing; 2004. Available from: https://www.waters.com/waters/enIN/ACQUITY-UPLC-PDADetector/nav.htm?locale=enINandcid= 514225 [Last accessed on 10 Feb 2020]
Antony B, Benny M, Kuruvilla BT, Gupta NK. A validated ultra-performance liquid chromatography method for nitrate and nitrite measurement. Asian J Pharm Clin Res 2018;11:257-63.
Palakdeep Kaur, Mohit Kumar, Mandal UK. Development and validation of a simple HPLC method for estimation of mycophenolate mofetil in microemulsion formulation. Int J Pharm Pharm Sci 2020;1:16-20.