Background: A simple, sensitive and precise spectrodensitometric method has been developed and validated for simultaneous determination of sofosbuvir, ribavirin and saxagliptin in their pure and pharmaceutical dosage forms. Methods: The method employed TLC plates precoated with silica gel G 60 F254 as the stationary phase. The mobile phase consisting of acetonitrile-water (80:20, v/v) was used to give compact bands for all the studied drugs at 228 nm. They were resolved with retardation factor (Rf) values of 0.71, 0.36 and 0.21 for sofosbuvir, ribavirin and saxagliptin respectively. Results: The linearity ranges were 400 – 10000 ng/band for all the studied drugs. Limits of detection were 124.78, 124.31 and 128.29 and limits of quantitation were 378.13, 376.71, 388.77 ng/band for sofosbuvir, ribavirin and saxagliptin, respectively. Correlation coefficient (r) values were 0.9993, 0.9995 and 0.9991 for sofosbuvir, ribavirin and saxagliptin, respectively. Conclusion: The method was validated according to ICH guidelines and has been successfully applied for the determination of the studied drugs in their pure and dosage forms without any interference from the commonly encountered excipients.

Background: A simple, sensitive and precise spectrodensitometric method has been developed and validated for simultaneous determination of sofosbuvir, ribavirin and saxagliptin in their pure and pharmaceutical dosage forms. Methods: The method employed TLC plates precoated with silica gel G 60 F254 as the stationary phase. The mobile phase consisting of acetonitrile-water (80:20, v/v) was used to give compact bands for all the studied drugs at 228 nm. They were resolved with retardation factor (Rf) values of 0.71, 0.36 and 0.21 for sofosbuvir, ribavirin and saxagliptin respectively. Results: The linearity ranges were 400 – 10000 ng/band for all the studied drugs. Limits of detection were 124.78, 124.31 and 128.29 and limits of quantitation were 378.13, 376.71, 388.77 ng/band for sofosbuvir, ribavirin and saxagliptin, respectively. Correlation coefficient (r) values were 0.9993, 0.9995 and 0.9991 for sofosbuvir, ribavirin and saxagliptin, respectively. Conclusion: The method was validated according to ICH guidelines and has been successfully applied for the determination of the studied drugs in their pure and dosage forms without any interference from the commonly encountered excipients.

Background: A simple, sensitive and precise spectrodensitometric method has been developed and validated for simultaneous determination of sofosbuvir, ribavirin and saxagliptin in their pure and pharmaceutical dosage forms. Methods: The method employed TLC plates precoated with silica gel G 60 F254 as the stationary phase. The mobile phase consisting of acetonitrile-water (80:20, v/v) was used to give compact bands for all the studied drugs at 228 nm. They were resolved with retardation factor (Rf) values of 0.71, 0.36 and 0.21 for sofosbuvir, ribavirin and saxagliptin respectively. Results: The linearity ranges were 400 – 10000 ng/band for all the studied drugs. Limits of detection were 124.78, 124.31 and 128.29 and limits of quantitation were 378.13, 376.71, 388.77 ng/band for sofosbuvir, ribavirin and saxagliptin, respectively. Correlation coefficient (r) values were 0.9993, 0.9995 and 0.9991 for sofosbuvir, ribavirin and saxagliptin, respectively. Conclusion: The method was validated according to ICH guidelines and has been successfully applied for the determination of the studied drugs in their pure and dosage forms without any interference from the commonly encountered excipients.

Background: A simple, sensitive and precise spectrodensitometric method has been developed and validated for simultaneous determination of sofosbuvir, ribavirin and saxagliptin in their pure and pharmaceutical dosage forms. Methods: The method employed TLC plates precoated with silica gel G 60 F254 as the stationary phase. The mobile phase consisting of acetonitrile-water (80:20, v/v) was used to give compact bands for all the studied drugs at 228 nm. They were resolved with retardation factor (Rf) values of 0.71, 0.36 and 0.21 for sofosbuvir, ribavirin and saxagliptin respectively. Results: The linearity ranges were 400 – 10000 ng/band for all the studied drugs. Limits of detection were 124.78, 124.31 and 128.29 and limits of quantitation were 378.13, 376.71, 388.77 ng/band for sofosbuvir, ribavirin and saxagliptin, respectively. Correlation coefficient (r) values were 0.9993, 0.9995 and 0.9991 for sofosbuvir, ribavirin and saxagliptin, respectively. Conclusion: The method was validated according to ICH guidelines and has been successfully applied for the determination of the studied drugs in their pure and dosage forms without any interference from the commonly encountered excipients.

Sofosbuvir (SOF) and ledipasvir (LDS) represent anti-hepatitis C binary mixture. Herein, a fast high-performance thin-layer chromatography (HPTLC) method was developed, validated and applied for simultaneous determination of SOF and LDS in biological matrix. An innovative strategy was designed which based on coupling dual wavelength detection with HPTLC. This strategy enabled sensitive, specific, high sample throughput and costeffective determination of the SOF-LDS binary mixture. The developed HPTLC procedure is based on a simple liquid–liquid extraction, enrichment of the analytes and subsequent separation with UV detection. Separations were performed on HPTLC silica gel 60 F254 aluminum plates with a mobile phase consisting of ethyl acetate–glacial acetic acid (100:5, v/v). The Rf values for SOF and LDS were 0.62 and 0.30, respectively. Dual wavelength scanning was carried out in the absorbance mode at 265 and 327 nm for SOF and LDS, respectively. The linear ranges were 40–640 and 9–144 ng/band for SOF and LDS, respectively with correlation coefficients of 0.9998. The detection limits were 10.61 and 2.54 ng/band and the quantitation limits were 32.14 and 7.70 ng/band for SOF and LDS, respectively indicating high sensitivity of the proposed method. Consequently, this permits in vitro and in vivo application of the proposed method in rabbit plasma with good percentage recovery(95.68–103.26%). Validation parameters were assessed according to ICH guidelines. The proposed method represents a simple, high sample throughput and economic alternative to the already existing more complicated reported LC-MS/MS techniques. The method would afford an efficient tool for therapeutic drug monitoring and bioavailability studies of SOF and LDS.

Sofosbuvir (SOF) and ledipasvir (LDS) represent anti-hepatitis C binary mixture. Herein, a fast high-performance thin-layer chromatography (HPTLC) method was developed, validated and applied for simultaneous determination of SOF and LDS in biological matrix. An innovative strategy was designed which based on coupling dual wavelength detection with HPTLC. This strategy enabled sensitive, specific, high sample throughput and costeffective determination of the SOF-LDS binary mixture. The developed HPTLC procedure is based on a simple liquid–liquid extraction, enrichment of the analytes and subsequent separation with UV detection. Separations were performed on HPTLC silica gel 60 F254 aluminum plates with a mobile phase consisting of ethyl acetate–glacial acetic acid (100:5, v/v). The Rf values for SOF and LDS were 0.62 and 0.30, respectively. Dual wavelength scanning was carried out in the absorbance mode at 265 and 327 nm for SOF and LDS, respectively. The linear ranges were 40–640 and 9–144 ng/band for SOF and LDS, respectively with correlation coefficients of 0.9998. The detection limits were 10.61 and 2.54 ng/band and the quantitation limits were 32.14 and 7.70 ng/band for SOF and LDS, respectively indicating high sensitivity of the proposed method. Consequently, this permits in vitro and in vivo application of the proposed method in rabbit plasma with good percentage recovery(95.68–103.26%). Validation parameters were assessed according to ICH guidelines. The proposed method represents a simple, high sample throughput and economic alternative to the already existing more complicated reported LC-MS/MS techniques. The method would afford an efficient tool for therapeutic drug monitoring and bioavailability studies of SOF and LDS.

Sofosbuvir (SOF) and ledipasvir (LDS) represent anti-hepatitis C binary mixture. Herein, a fast high-performance thin-layer chromatography (HPTLC) method was developed, validated and applied for simultaneous determination of SOF and LDS in biological matrix. An innovative strategy was designed which based on coupling dual wavelength detection with HPTLC. This strategy enabled sensitive, specific, high sample throughput and costeffective determination of the SOF-LDS binary mixture. The developed HPTLC procedure is based on a simple liquid–liquid extraction, enrichment of the analytes and subsequent separation with UV detection. Separations were performed on HPTLC silica gel 60 F254 aluminum plates with a mobile phase consisting of ethyl acetate–glacial acetic acid (100:5, v/v). The Rf values for SOF and LDS were 0.62 and 0.30, respectively. Dual wavelength scanning was carried out in the absorbance mode at 265 and 327 nm for SOF and LDS, respectively. The linear ranges were 40–640 and 9–144 ng/band for SOF and LDS, respectively with correlation coefficients of 0.9998. The detection limits were 10.61 and 2.54 ng/band and the quantitation limits were 32.14 and 7.70 ng/band for SOF and LDS, respectively indicating high sensitivity of the proposed method. Consequently, this permits in vitro and in vivo application of the proposed method in rabbit plasma with good percentage recovery(95.68–103.26%). Validation parameters were assessed according to ICH guidelines. The proposed method represents a simple, high sample throughput and economic alternative to the already existing more complicated reported LC-MS/MS techniques. The method would afford an efficient tool for therapeutic drug monitoring and bioavailability studies of SOF and LDS.

Sofosbuvir (SOF) and ledipasvir (LDS) represent anti-hepatitis C binary mixture. Herein, a fast high-performance thin-layer chromatography (HPTLC) method was developed, validated and applied for simultaneous determination of SOF and LDS in biological matrix. An innovative strategy was designed which based on coupling dual wavelength detection with HPTLC. This strategy enabled sensitive, specific, high sample throughput and costeffective determination of the SOF-LDS binary mixture. The developed HPTLC procedure is based on a simple liquid–liquid extraction, enrichment of the analytes and subsequent separation with UV detection. Separations were performed on HPTLC silica gel 60 F254 aluminum plates with a mobile phase consisting of ethyl acetate–glacial acetic acid (100:5, v/v). The Rf values for SOF and LDS were 0.62 and 0.30, respectively. Dual wavelength scanning was carried out in the absorbance mode at 265 and 327 nm for SOF and LDS, respectively. The linear ranges were 40–640 and 9–144 ng/band for SOF and LDS, respectively with correlation coefficients of 0.9998. The detection limits were 10.61 and 2.54 ng/band and the quantitation limits were 32.14 and 7.70 ng/band for SOF and LDS, respectively indicating high sensitivity of the proposed method. Consequently, this permits in vitro and in vivo application of the proposed method in rabbit plasma with good percentage recovery(95.68–103.26%). Validation parameters were assessed according to ICH guidelines. The proposed method represents a simple, high sample throughput and economic alternative to the already existing more complicated reported LC-MS/MS techniques. The method would afford an efficient tool for therapeutic drug monitoring and bioavailability studies of SOF and LDS.

High shear wet granulation is a significant component procedure in the pharmaceutical industry. The objective of the study was to investigate the influence of two independent formulation variables; polyvinypyrrolidone (PVP) as a binder (X1) and croscarmellose sodium (CCS) as a disintegrant (X2) on the critical quality attributes of acetaminophen granules and their corresponding tablets using design of experiment (DoE) approach. A two factor, three level (32) full factorial design has been applied; each variable was investigated at three levels to characterize their strength and interaction. The dried granules have been analyzed for their density, granule size and flowability. Additionally, the produced tablets have been investigated for: breaking force, friability, disintegration time and t80 of drug dissolution. The analysis of variance (ANOVA) showed that the two variables had a significant impact (p 0.05) on granules and tablets characteristics, while only the binder concentration influenced the tablets friability. Furthermore, significant interactions (p 0.05) between the two variables, for granules and tablets attributes, were also found. However, variables interaction showed minimal effect for granules flowability as well as tablets friability. Desirability function was carried out to optimize the variables under study to obtain product within the USP limit. It was found that the higher desirability (0.985) could be obtained at the medium level of PVP and low level of CCS. Ultimately, this study supplies the formulator with beneficial tools in selecting the proper level of binder and disintegrant to attain product with desired characteristics.

High shear wet granulation is a significant component procedure in the pharmaceutical industry. The objective of the study was to investigate the influence of two independent formulation variables; polyvinypyrrolidone (PVP) as a binder (X1) and croscarmellose sodium (CCS) as a disintegrant (X2) on the critical quality attributes of acetaminophen granules and their corresponding tablets using design of experiment (DoE) approach. A two factor, three level (32) full factorial design has been applied; each variable was investigated at three levels to characterize their strength and interaction. The dried granules have been analyzed for their density, granule size and flowability. Additionally, the produced tablets have been investigated for: breaking force, friability, disintegration time and t80 of drug dissolution. The analysis of variance (ANOVA) showed that the two variables had a significant impact (p 0.05) on granules and tablets characteristics, while only the binder concentration influenced the tablets friability. Furthermore, significant interactions (p 0.05) between the two variables, for granules and tablets attributes, were also found. However, variables interaction showed minimal effect for granules flowability as well as tablets friability. Desirability function was carried out to optimize the variables under study to obtain product within the USP limit. It was found that the higher desirability (0.985) could be obtained at the medium level of PVP and low level of CCS. Ultimately, this study supplies the formulator with beneficial tools in selecting the proper level of binder and disintegrant to attain product with desired characteristics.