Stability Indicating HPLC Method for Quantification of Solifenacin Succinate &amp;amp; Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form

Ganthi, Hari Kishan Reddy; P, Raveendra Reddy; Park, Young Jun; Bapatu, Hanimi Reddy; Cho, Woo Hyong

doi:10.4236/ajac.2016.711073

Cited by 26 publications

(19 citation statements)

References 8 publications

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“…It acts by increasing the levels of intracellular cyclic guanosine monophosphate in smooth muscles of the bladder neck and prostate which in turn reduces contractility tone and improves urine flow [15]. On reviewing literature, TMS was quantified by several methods, namely; TLC [16][17][18], HPLC in different matrices [18][19][20][21], capillary electrophoresis [16], spectrophotometry [16,[22][23][24], and electrochemical methods [16,25]. For TAD, several methods were reported for its determination includ-ing TLC [26][27][28][29], HPLC [26,[30][31][32][33][34][35][36], gas chromatography [26,37], capillary electrophoresis [26], spectrophotometry [26,[38][39][40][41], and electrochemical methods [42][43][44].…”

Section: Introductionmentioning

confidence: 99%

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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The advent of a new pharmaceutical formulation evokes the need for examining the chemical stability of their constituents and establishing proper stability‐indicating methods. Herein, the stability of the newly co‐formulated Tamsulosin and Tadalafil were examined under different stress conditions. The acidic degradation of Tamsulosin yielded its sulfonated derivative, while Tadalafil was susceptible to both acidic and basic degradation. Two stability‐indicating chromatographic methods, namely; high‐performance thin‐layer chromatography and high‐performance liquid chromatography, have been developed. Significant high‐performance thin‐layer chromatography‐fractionation could be achieved by utilizing a stationary phase of silica gel 60 F254 and a mobile phase composed of ethyl acetate/toluene/methanol/ammonia (4:2:4:0.6, by volumes) with densitometric recording at 280 nm over a concentration range of 0.5–25 μg/band for both drugs. The HPLC‐separation could be reached on XBridge® C18 column isocraticaly by using a mobile phase having acetonitrile/phosphate buffer, pH 6.0 (45:55, v/v) pumped at a flow rate of 1.7 mL/min and applying diode array ultraviolet‐detection at 210 nm over a linearity range of 3–70 μg/mL for each drug. Specificity of the two methods was additionally assured via peak purity assessment. Moreover, the methods were distinctly exploited for evaluating the drugs’ stability in accelerated stability‐studied samples of Tamplus® capsules.

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Section: Introductionmentioning

confidence: 99%

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Rezk

Abdel-Moety

Wadie

et al. 2020

J of Separation Science

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“…It is shorter than the methods in the literature. In addition, in our method, solifenacine succinate is eluted in less time than the reported methods 19,[21][22][23] . The low injection volume 17,16 and mobile phase flow rate 18 of the method we developed provide an advantage for less chemical consumption than the reported methods.…”

Section: Discussionmentioning

confidence: 92%

“…In addition, these methods include complex sample preparation and derivatization steps 11,13,15 . The HPLC methods in the literature, on the other hand, lead to a loss of time and solvent consumption due to long analysis periods of approximately 30 minutes 17,18,21,22 . The total analysis time of the present method is 7 minutes.…”

Section: Discussionmentioning

confidence: 99%

“…Different analytical methods for the determination of solifenacin succinate alone or in combination with other drugs, are available in the literature. These methods are as follows; spectrophotometry [11][12][13][14][15] , HPLC [16][17][18][19][20][21][22][23] and LC-MS-MS [24][25][26] methods. Therefore, in this study; It is aimed to develop an accurate, sensitive and simple method for determination of solifenacin succinate in spiked human plasma and pharmaceutical formulations.…”

Section: Introductionmentioning

confidence: 99%

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Determination of solifenacin succinate in human plasma and pharmaceutical formulations using HPLC-UV

Akman¹,

Kadıoğlu²

2019

Bioorg. Med. Chem. Rep.

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An accurate, rapid and precise high performance liquid chromatographic coupled with ultraviolet detector method has been developed for the determination of solifenacin succinate in pharmaceutical formulation and human plasma. Quantitative analysis of solifenacin succinate was performed using a C18 column at wavelength at 210 nm. The mobile phase consisted of 10 mM ammonium formate buffer (pH 4.0), acetonitrile and methanol (52.5:32.5:12.5 v/v/v). The method showed linearity in the concentration range of 3-60 μg/mL and the correlation coefficient was 0.9998 and 0.9994 for the standard and human plasma solutions, respectively. The proposed method was within acceptable limits in terms of accuracy, precision, selectivity, linearity, sensitivity and recovery parameters. This method is readily applicable for the determination of solifenacin succinate in human plasma and pharmaceutical formulations.

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“…Literature survey reveals spectrophotometric methods [4][5][6][7][8] , High Performance Liquid Chromatography (HPLC) [9][10][11] and Liquid Chromatography-Electrospray Ionization-Mass Spectrometry (LC-ESI-MS/MS) [11][12] methods were available for tamsulosin hydrochloride and Ultraviolet [13][14] , HPLC [15][16] , Ultra-Performance Liquid Chromatography (UPLC) [17] , high-performance thin layer chromatography (HPTLC) [18] and Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) [19][20] methods were available for estimation of solifinacin succinate. Only few reverse phase high performance liquid chromatography (RP-HPLC) [21][22] method and spectrofluorimetric [23] methods were reported for the estimation of solifinacin succinate & tamsulosin hydrochloride in combination dosage forms. However no UV spectrophotometric method is reported yet for the estimation of solifinacin succinate & tamsulosin hydrochloride in combination dosage forms.…”

Section: Chemically Tamsulosin Hydrochloride Is 5-[(2r)-2-{[2-(2-ethoxyphenoxy)ethyl]mentioning

confidence: 99%

Simultaneous Estimation of Solifenacin Succinate and Tamsulosin Hydrochloride in Combined Dosage Form by Using First Order Derivative Spectrophotometric Method

Yarraguntla¹,

Kumar²,

Ponnam³

et al. 2021

ijps

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Srinivasarao et al.: Derivative Spectrophotometric Method for Solifenacin Succinate and Tamsulosin HydrochlorideUsing first-order derivative techniques, a simple accurate and precise Ultraviolet spectrophotometric method was developed for the determination of solifenacin succinate and tamsulosin hydrochloride in combined dosage form. Every solifinacin succinate and tamsulosin hydrochloride was scanned in the wavelength region of 200-400 nm for determination of sampling wavelengths and selected sampling wavelengths were selected. Sampling wavelengths were chosen at 265 nm (zero crossing of solifinacin succinate) where the absorbance of tamsulosin hydrochloride was important and at 250 nm (zero crossing of tamsulosin hydrochloride) where the absorbance of solifinacin succinate was significant. For solifenacin succinate, linearity ranged from 10 to 100 μg/ml with a correlation coefficient of 0.998 and 2 to 10 μg/ml for the correlation coefficient of tamsulosin hydrochloride is 0.9988. The median recovery was considered to be satisfactory. For the routine study of solifenacin succinate and tamsulosin hydrochloride in combined dosage forms, the approach proposed can be applied.

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Stability Indicating HPLC Method for Quantification of Solifenacin Succinate & Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form

Cited by 26 publications

References 8 publications

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Stability assessment of tamsulosin and tadalafil co‐formulated in capsules by two validated chromatographic methods

Determination of solifenacin succinate in human plasma and pharmaceutical formulations using HPLC-UV

Simultaneous Estimation of Solifenacin Succinate and Tamsulosin Hydrochloride in Combined Dosage Form by Using First Order Derivative Spectrophotometric Method

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