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Journal of Chromatographic Science
Stability indicating a reverse-phase HPLC analytical method for the quantification of tamoxifen c... more Stability indicating a reverse-phase HPLC analytical method for the quantification of tamoxifen citrate (TMX) in the bulk and lipidic nano-vesicles (LNVs) was developed. The optimized method was validated according to the ICH Q2 (R1) guidelines by following a three-factor interaction Box–Behnken design using Design-Expert® software. The responses measured at 236 nm were retention time (Rt), peak area, tailing factor (TF) and the number of theoretical plates. TMX was eluted best using the Luna® C18 LC Column along with a mobile phase of methanol (MeOH) and ammonium acetate buffer (AAB pH 4.5) 80:20 v/v mixture at 25 ± 2°C temperature. The currently developed method was linear in 100-5,000 ng/mL range with a detection limit of 4.55 ng/mL and a quantification limit of 13.78 ng/mL. The optimized method was utilized to evaluate the stability of TMX in different stress conditions by performing forced degradation studies. The results from the degradation study stipulated that on exposure t...
Journal of Drug Delivery Science and Technology
Current Pharmaceutical Design
Background: Nanosponge, as a carrier for the skin delivery system for drugs, plays a vital role. ... more Background: Nanosponge, as a carrier for the skin delivery system for drugs, plays a vital role. It not only serves to administer the drug to the targeted layer of skin but also increases the drug retention and deposition on the skin. Objective: In this review, we aim to highlight the effects of several processes and formulation variables prompting the characteristics of various nanosponges for the delivery of drugs into/ across the skin. Method: In the present review article, the overall introduction of nanosponges, their preparation, characteristic features, advantages, disadvantages, and factors affecting their preparation, are covered. Furthermore, an elaborative description of nanosponges for skin delivery and its toxicological perspective with some referential examples of nanosponge drugs has also been deliberated here. Results: Factors associated with the formation of nanosponges can directly or indirectly affect its efficacy in the skin delivery of drugs. These nanoforms are...
Chromatographia
Stability-indicating reverse-phase HPLC analytical method for the quantification of Paclitaxel (P... more Stability-indicating reverse-phase HPLC analytical method for the quantification of Paclitaxel (PTX) in the bulk and cationic liposomes was developed. The optimized method was validated according to the ICH Q2 (R1) guidelines by following a 2-level–4-factor interaction Box–Behnken design using Design-Expert® software. The responses measured at 228 nm were retention time (Rt), peak area, tailing factor (Tf10%), and the number of theoretical plates (NTP). PTX was eluted best using the Luna® C18 LC Column along with a mobile phase of methanol and 25 mM ammonium acetate buffer (pH 6) 75:25 v/v mixture at 25 ± 2 °C temperature. The currently developed method was linear in the 2.5–100 µg/mL range with a detection limit of 0.062 µg/mL and a quantification limit of 0.188 µg/mL. The optimized method was utilized to evaluate the stability of PTX in different stress conditions by performing forced degradation studies. The results from the degradation study stipulated that on exposure to variou...
Journal of Chromatographic Science, 2021
A stability-indicating reverse phase high-performance liquid chromatography method was developed ... more A stability-indicating reverse phase high-performance liquid chromatography method was developed and validated for simultaneous quantification of apremilast (APL) and betamethasone dipropionate (BD) in bulk as well as drug loaded microsponges. Various mobile phase systems were screened to check the system suitability followed by force degradation analysis to determine APL and BD stability under varying stress conditions. A central composite design model was used to optimize the column temperature and flow rate using Design Expert® (9.0.1). One factor at a time approach with five independent factors were used to validate the robustness of the method. Finally, APL and BD were precisely and accurately quantified from drug loaded microsponges using the validated method. A favorable separation of APL and BD was obtained on a Phenomenex® Luna C18 column using a mixture of 50 mM phosphate buffer containing 0.1% triethylamine (pH 6.1) and acetonitrile (60:40%v/v) as mobile phase. Both the d...
Journal of chromatographic science, 2021
A novel isocratic stability-indicating chromatographic method was developed, optimized and valida... more A novel isocratic stability-indicating chromatographic method was developed, optimized and validated using Design-Expert® following ICH guidelines for the quantification of Timolol maleate (TM). The intrinsic stability of TM was assessed by force degradation studies, which concluded no extensive degradation except under alkaline and oxidative conditions. TM was quantified accurately in the surfactant-based elastic vesicular system by separating it on Hypersil BDS C8 column using triethylamine in H2O (0.15%v/v; pH 3.0) and acetonitrile (ACN; 65:35%v/v). The influence of variable factors like mobile phase pH, injection volume (μL), flow rate (mL/min) and ACN content (%) on method responses were assessed using a full factorial design. The method was linear between 0.05 and 10 μg/mL with an R2 value of 0.9993. Limit of detection and limit of quantification were found to be 0.90 and 27.2 ng/mL. The method was specific, with recovery in plain drug solution of 89-92% and elastic nanovesicl...
Oxford University Press, 2021
A stability-indicating reverse phase high-performance liquid chromatography method was developed ... more A stability-indicating reverse phase high-performance liquid chromatography method was developed and validated for simultaneous quantification of apremilast (APL) and betamethasone dipropionate (BD) in bulk as well as drug loaded microsponges. Various mobile phase systems were screened to check the system suitability followed by force degradation analysis to determine APL and BD stability under varying stress conditions. A central composite design model was used to optimize the column temperature and flow rate using Design Expert ® (9.0.1). One factor at a time approach with five independent factors were used to validate the robustness of the method. Finally, APL and BD were precisely and accurately quantified from drug loaded microsponges using the validated method. A favorable separation of APL and BD was obtained on a Phenomenex ® Luna C18 column using a mixture of 50 mM phosphate buffer containing 0.1% triethylamine (pH 6.1) and acetonitrile (60:40%v/v) as mobile phase. Both the drugs were found to be stable when exposed to stressors such as heat-, light-, alkali-, acid-and peroxide-induced degradation. The calibration curves were found to be linear with appreciable limit of detection and limit of quantification. Recovery and percentage relative standard deviation of peak areas for APL and BD were found to be < 2.0% and 99-100% in bulk drug solution and <2.0% and 99-103% in microsponge formulation, respectively. Statistical analysis using analysis of variance indicated that the model was significant (P < 0.001). Hence, the developed method can be effectively used to quantify APL and BD, both in bulk as well as microsponge formulations.
Journal of Separation Science
Journal of Ethnopharmacology
Journal of Chromatographic Science
Stability indicating a reverse-phase HPLC analytical method for the quantification of tamoxifen c... more Stability indicating a reverse-phase HPLC analytical method for the quantification of tamoxifen citrate (TMX) in the bulk and lipidic nano-vesicles (LNVs) was developed. The optimized method was validated according to the ICH Q2 (R1) guidelines by following a three-factor interaction Box–Behnken design using Design-Expert® software. The responses measured at 236 nm were retention time (Rt), peak area, tailing factor (TF) and the number of theoretical plates. TMX was eluted best using the Luna® C18 LC Column along with a mobile phase of methanol (MeOH) and ammonium acetate buffer (AAB pH 4.5) 80:20 v/v mixture at 25 ± 2°C temperature. The currently developed method was linear in 100-5,000 ng/mL range with a detection limit of 4.55 ng/mL and a quantification limit of 13.78 ng/mL. The optimized method was utilized to evaluate the stability of TMX in different stress conditions by performing forced degradation studies. The results from the degradation study stipulated that on exposure t...
Journal of Drug Delivery Science and Technology
Current Pharmaceutical Design
Background: Nanosponge, as a carrier for the skin delivery system for drugs, plays a vital role. ... more Background: Nanosponge, as a carrier for the skin delivery system for drugs, plays a vital role. It not only serves to administer the drug to the targeted layer of skin but also increases the drug retention and deposition on the skin. Objective: In this review, we aim to highlight the effects of several processes and formulation variables prompting the characteristics of various nanosponges for the delivery of drugs into/ across the skin. Method: In the present review article, the overall introduction of nanosponges, their preparation, characteristic features, advantages, disadvantages, and factors affecting their preparation, are covered. Furthermore, an elaborative description of nanosponges for skin delivery and its toxicological perspective with some referential examples of nanosponge drugs has also been deliberated here. Results: Factors associated with the formation of nanosponges can directly or indirectly affect its efficacy in the skin delivery of drugs. These nanoforms are...
Chromatographia
Stability-indicating reverse-phase HPLC analytical method for the quantification of Paclitaxel (P... more Stability-indicating reverse-phase HPLC analytical method for the quantification of Paclitaxel (PTX) in the bulk and cationic liposomes was developed. The optimized method was validated according to the ICH Q2 (R1) guidelines by following a 2-level–4-factor interaction Box–Behnken design using Design-Expert® software. The responses measured at 228 nm were retention time (Rt), peak area, tailing factor (Tf10%), and the number of theoretical plates (NTP). PTX was eluted best using the Luna® C18 LC Column along with a mobile phase of methanol and 25 mM ammonium acetate buffer (pH 6) 75:25 v/v mixture at 25 ± 2 °C temperature. The currently developed method was linear in the 2.5–100 µg/mL range with a detection limit of 0.062 µg/mL and a quantification limit of 0.188 µg/mL. The optimized method was utilized to evaluate the stability of PTX in different stress conditions by performing forced degradation studies. The results from the degradation study stipulated that on exposure to variou...
Journal of Chromatographic Science, 2021
A stability-indicating reverse phase high-performance liquid chromatography method was developed ... more A stability-indicating reverse phase high-performance liquid chromatography method was developed and validated for simultaneous quantification of apremilast (APL) and betamethasone dipropionate (BD) in bulk as well as drug loaded microsponges. Various mobile phase systems were screened to check the system suitability followed by force degradation analysis to determine APL and BD stability under varying stress conditions. A central composite design model was used to optimize the column temperature and flow rate using Design Expert® (9.0.1). One factor at a time approach with five independent factors were used to validate the robustness of the method. Finally, APL and BD were precisely and accurately quantified from drug loaded microsponges using the validated method. A favorable separation of APL and BD was obtained on a Phenomenex® Luna C18 column using a mixture of 50 mM phosphate buffer containing 0.1% triethylamine (pH 6.1) and acetonitrile (60:40%v/v) as mobile phase. Both the d...
Journal of chromatographic science, 2021
A novel isocratic stability-indicating chromatographic method was developed, optimized and valida... more A novel isocratic stability-indicating chromatographic method was developed, optimized and validated using Design-Expert® following ICH guidelines for the quantification of Timolol maleate (TM). The intrinsic stability of TM was assessed by force degradation studies, which concluded no extensive degradation except under alkaline and oxidative conditions. TM was quantified accurately in the surfactant-based elastic vesicular system by separating it on Hypersil BDS C8 column using triethylamine in H2O (0.15%v/v; pH 3.0) and acetonitrile (ACN; 65:35%v/v). The influence of variable factors like mobile phase pH, injection volume (μL), flow rate (mL/min) and ACN content (%) on method responses were assessed using a full factorial design. The method was linear between 0.05 and 10 μg/mL with an R2 value of 0.9993. Limit of detection and limit of quantification were found to be 0.90 and 27.2 ng/mL. The method was specific, with recovery in plain drug solution of 89-92% and elastic nanovesicl...
Oxford University Press, 2021
A stability-indicating reverse phase high-performance liquid chromatography method was developed ... more A stability-indicating reverse phase high-performance liquid chromatography method was developed and validated for simultaneous quantification of apremilast (APL) and betamethasone dipropionate (BD) in bulk as well as drug loaded microsponges. Various mobile phase systems were screened to check the system suitability followed by force degradation analysis to determine APL and BD stability under varying stress conditions. A central composite design model was used to optimize the column temperature and flow rate using Design Expert ® (9.0.1). One factor at a time approach with five independent factors were used to validate the robustness of the method. Finally, APL and BD were precisely and accurately quantified from drug loaded microsponges using the validated method. A favorable separation of APL and BD was obtained on a Phenomenex ® Luna C18 column using a mixture of 50 mM phosphate buffer containing 0.1% triethylamine (pH 6.1) and acetonitrile (60:40%v/v) as mobile phase. Both the drugs were found to be stable when exposed to stressors such as heat-, light-, alkali-, acid-and peroxide-induced degradation. The calibration curves were found to be linear with appreciable limit of detection and limit of quantification. Recovery and percentage relative standard deviation of peak areas for APL and BD were found to be < 2.0% and 99-100% in bulk drug solution and <2.0% and 99-103% in microsponge formulation, respectively. Statistical analysis using analysis of variance indicated that the model was significant (P < 0.001). Hence, the developed method can be effectively used to quantify APL and BD, both in bulk as well as microsponge formulations.
Journal of Separation Science
Journal of Ethnopharmacology