Prajapati P.B

Uka Tarsadia University · Quality Assurance

Background: The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN) and telmisartan (TST) is used for the management of hypertension. Numerous RP-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN and TST. According to the concept of green analytical chemistry (GAC), toxic organic s...

Background: The fixed-dose combination (FDC) of vildagliptin (VDG) and remogliflozin etabonate (RGE) is used as anti-diabetic medicine. Numerous RP-HPLC methods have been reported for the estimation of VDG and RGE using toxic organic solvents such as acetonitrile and methanol. These organic solvents are also hazardous to the environment. Objectiv...

Background According to the literature review, organic solvents such as methanol, acetonitrile, toluene, and carbon tetrachloride have been used for the chromatographic analysis of aripiprazole (APZ). The green chemistry approach recommends these organic solvents are unsafe for analysts and the environment and should be avoided or minimised in chro...

According to the green chemistry approach, the usage of carcinogenic and teratogenic organic solvents should be minimized in the development of the analytical method for the safety of the environment and analysts. According to the literature review, no high-performance thin-layer chromatographic (HPTLC) method has been reported yet for concomitant...

Background Azilsartan medoxomil (AZL) is an anti-hypertensive drug and its numerous FDCs are used for the treatment of hypertension. Numerous chromatographic methods have been reported for the estimation of FDCs of AZL. But analyst has to establish a separate chromatographic condition for the analysis of each FDC of AZL. No RP-HPLC method has been...

Background According to the green chemistry approach, during method development, the usage of toxic and carcinogenic organic solvents should be avoided or minimized for the safety of the environment and analysts. The chromatographic methods such as RP-HPLC and HPTLC include the usage of class 2 organic solvents as per ICH Q3C (R6) guideline. The ch...

Metformin HCl (MET) is a mostly used antidiabetic drug and several fixed-dose combinations are available in the market with other antidiabetic drugs for the treatment of insulin-independent diabetes. Numerous chromatographic methods have been reported for the estimation of multiple fixed dose combination (FDC) of MET but each FDC needs a separate a...

Hypertension is the most prominent disease found in people due to stressful routines and the working environment. The fixed-dose combination (FDC) of azilsartan medoxomil (AZL) and cilnidipine (CLN) is used for the treatment of hypertension. According to the green chemistry approach, organic solvents should be minimized in the development of the an...

Background Numerous fixed-dose combinations (FDCs) of cilnidipine (CIL) with chlorthalidone (CLT) and azilsartan medoxomil (AZL) are used for the treatment of hypertension. Numerous RP-HPLC and HPTLC methods have been reported in the literature for the estimation of FDCs of CIL. But no HPTLC method has been reported yet for synchronous estimation o...

Numerous reversed-phase high-pressure liquid chromatography (RP-HPLC) and high-performance thin-layer chromatography (HPTLC) techniques have been published for the estimation of fixed-dose combinations (FDCs) of telmisartan (TEL). No published literature has been reported to date which described the synchronous estimation of FDCs of TEL using a sin...

Background Metformin hydrochloride is the first choice antihyperglycemic agent and its several fixed-dose combinations (FDCs) with pioglitazone hydrochloride, sitagliptin phosphate and gliclazide are used for the management of type II diabetes. Numerous RP-HPLC and HPTLC methods have been reported for estimation of FDCs of metformin but each FDC ne...

A robust HPTLC method has been developed for simultaneous estimation of metronidazole and ofloxacin by enhanced analytical quality by design (AQbD) approach using DoE- and risk-based DMAIC principle. The risk-based DMAIC principle was implemented by identification of potential method risk parameters followed by risk assessment by RPN ranking and fi...

According to the upcoming ICH Q14 guideline, the development of an analytical method by the implementation of the AQbD approach based on analytical quality risk management and design of experiments will become a regulatory requirement for the registration of new drug substances and products. In literature, the HPTLC method has not been reported yet...

The combination of carvedilol (CAR) and ivabradine (IVA) is used for a greater reduction in heart rate and for achieving better exercise capacity in a patient with chronic heart failure. Numerous reverse-phase high-pressure liquid chromatography (RP-HPLC) and hyphenated techniques have been reported for the simultaneous estimation of CAR and IVA, b...

Dalfampridine is a potassium channel blocker used for the improvement of motor function in patients with multiple sclerosis. Numerous analytical techniques have been published in the literature for estimation of dalfampridine but no report has been found in the literature for estimation of dalfampridine in pharmaceutical dosage forms and human plas...

According to the literature review, numerous chromatographic methods have been published for estimation of fixed-dose combination products of telmisartan but no reverse-phase high-pressure liquid chromatographic (RP-HPLC) method has been published yet for synchronous estimation of fixed-dose combination (FDC) products of telmisartan to save time, c...

The fixed-dose combination (FDC) of montelukast sodium (MLS) and bilastine (BIL) is used for monotherapy in the patient with seasonal allergic rhinoconjuctivitis and asthma. According to the upcoming ICH (International Council for Harmonization) Q14 guideline, the development of the analytical method by the implementation of the Analytical Quality...

Background: In the recent scenario of green chemistry, the usage of organic solvent should be minimized in the development of the analytical method for the safety of the environment and analysts. Objective: Hence, the RP-HPLC method has been developed as an economical and eco-friendly alternative to published RP-HPLC methods for the analysis of...

Background The concomitant montelukast and bilastine are used as additive therapy for seasonal allergic rhinoconjuctivitis and mild to moderate asthma. According to the literature review, no UV-visible spectrophotometry method has been reported yet for simultaneous estimation of montelukast sodium and bilastine in their combined pharmaceutical dosa...

Telmisartan is an antihypertensive drug and several FDC products of telmisartan are available in the market for the treatment of hypertension. The multipurpose reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated as economical and eco-friendly alternative to numerous published chromatography methods...

Background Hypertension is a major health problem found in people throughout the world and numerous fixed-dose combination products of telmisartan are available in the local market for the treatment of hypertension. Several chromatography methods such as RP-HPLC and HPTLC methods have been published for estimation of FDC products of telmisartan wit...

Background: Bosutinib is a small molecule BCR-ABL, and src tyrosine kinase inhibitor used for the treatment of chronic myelogenous leukaemia. According to published literature, no stability-indicating RP-HPLC method has been reported yet for estimation of bosutinib. Objective: Hence, the stability-indicating RP-HPLC method has been developed for...

A precise, robust and accurate high-performance thin-layer chromatography (HPTLC) method has been developed for the simultaneous estimation of chlorthalidone and metoprolol succinate using analytical quality by design approach based on principles of quality risk management and design of experiments. The quality risk management was performed by the...

Background Numerous chromatography methods have been published for estimation of fixed-dose combinations (FDC) products of aspirin and ramipril with other drugs. But no published report has been found which promotes simultaneous estimation of some FDC of aspirin and ramipril with other drugs using a single chromatography condition. Objective Hence...

Background: Numerous RP-HPLC and HPTLC methods have been reported for estimation of fixed-dose combination (FDC) products of aspirin with anti-hypertensive and anti-lipidemic drugs. Each FDC of aspirin needed separate and dedicated chromatographic condition for its analysis. No Chromatography method has been reported yet for simultaneous estimatio...

Pranlukast hydrate is an anti-asthmatic drug and used in the treatment of acute asthma. Stability-indicating RP-HPLC method for pranlukast hydrate has been developed and validated. The reverse phase high performance liquid chromatographic method was developed using Shimadzu Column: Kromosil 100 C18 (150 mm × 4.6 mm × 5 μm) and mobile phase Acetonit...

Nowadays, the implementation of quality by design approach in analytical method development based on principles of quality risk management (QRM) and design of experiments (DoE) has became a regulatory requirement. Hence, a precise, accurate and robust high-performance thin-layer chromatography method has been developed for the simultaneous estimati...

The high-performance liquid chromatography method was only reported for simultaneous estimation of aspirin, simvastatin, ramipril, atenolol and hydrochlorothiazide in polycap capsule. High-performance thin-layer chromatography (HPTLC) method is now accepted as a method of analysis by many pharmaceutical industries and included as an official method...

Background Numbers of chromatography methods have been published in the literature for estimation of combined dosage forms of telmisartan. But each combined dosage form needs separate chromatography condition for analysis. Objective The versatile, economical, eco-friendly and robust (VEER) chromatographic method has been developed for simultaneous...

PurposeThe chromatography methods such as HPLC, HPTLC etc. were developed for simultaneous estimation of multiple fixed-dose combination products of metformin hydrochloride which need single chromatography condition to save solvent consumption. The method was developed by the implementation of analytical quality by design approach based on principl...

Failure mode critical effect analysis and design of experiment-based high performance thin layer chromatography (HPTLC) method has been developed for simultaneous estimation of lornoxicam (LOC) and eperisone hydrochloride (EPR). Failure modes were identified on the basis of prior knowledge and experimental data with the help of Ishikawa diagram for...

PurposeParacetamol is a well-known OTC drug, and several combinations are available in the market. The numbers of chromatography methods were published for analysis of combined pharmaceutical dosage form of paracetamol. But every combination needs separate and dedicated chromatography condition for analysis. Hence, a chromatography method was devel...

DoE based failure mode effect analysis has been performed for implementation of analytical quality by design approach in development of stability indicating assay method for estimation of apremilast. Failure modes were identified, categorized and listed in Ishikawa diagram on bases of preliminary experimentation and sound science of chromatography....

Quality risk assessment and design of experiment (DoE)-based quality by design (QbD) approach has been applied for the development of a stability-indicating assay method for acidic degradation kinetic study of apremilast. Quality risk assessment started with the identification of risk factors for method development by preliminary experimentation, p...

Analytical quality risk management (ICH Q9 guideline) concept based robust high performance thin layer chromatographic method has been developed with help of design of experiment (DoE) tool for simultaneous estimation of tizanidine hydrochloride and nimesulide in their combined pharmaceutical dosage forms. Risk identification and assessment were do...

A robust and eco-friendly stability-indicating high-performance thin-layer chromatography (HPTLC) method was developed for the stability study of thiocolchicoside using analytical quality-by-design approach. Full factorial design was used for screening potential variables affecting method development. Box-Behnken design was used subsequently for in...

Edoxaban Tosylate Monohydrate (EXN) is oral anticoagulant drug indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Sensitive and reproducible UV- Visible spectrophotometric method has been developed...

A sensitive, specific and precise high performance thin layer chromatographic method for estimation of Losartan potassium (LOS) and Ramipril (RAM) has been developed and validated. The method employed TLC aluminium plates pre-coated with silica gel 60 F254 as the stationary phase. The solvent system consisted of toluene: Methanol: Ethyl acetate (6:...

Dabigatran etexilate mesylate is an anticoagulant drug. Dabigatran demonstrated its efficacy for prophylaxis and treatment of thromboembolic event during orthopaedic surgery and curative treatment of hypercoagulability in atrial fibrillation. The present study deals with the development and validation of a stability-indicating high performance thin...

Two sensitive, accurate, and precise spectrophotometric methods have been developed and validated for the simultaneous estimation of ofloxacin (OFX), clotrimazole (CLZ), and lignocaine hydrochloride (LGN) in their combined dosage form (ear drops) without prior separation. The derivative ratio spectra method (method 1) includes the measurement of OF...

A rapid, sensitive, and stability-indicating high-performance thin-layer chromatographic method was developed and validated to study degradation kinetics of Alogliptin benzoate (ALG) in an alkaline medium. ALG was degraded under acidic, alkaline, oxidative, and thermal stress conditions. The degraded samples were chromatographed on silica gel 60F25...

The present research project involves development and validation of a stability-indicating HPTLC method for the estimation of naratriptan-HCl in their pharmaceutical dosage forms and its content uniformity testing. Naratriptan-HCl was subjected to alkaline, acidic, oxidative, neutral, thermal (dry heat) and photo-degradation conditions. The chromat...

Background: The combination of Amlodipine Besylaye, Hydrochlorthiazide and Telmisartan is prescribed for the treatment of hypertension. An Ultra Performance Liquid Chromatography (UPLC) method has been reported for simultaneous estimation of this combination. Objective: To develop and validate HPTLC Method for simultaneous estimation of Amlodipine...

Background: Balofloxacin is a third generation fluoroquinolone with a broad antibacterial spectrum ranging from gram-positive bacteria to gram-negative bacteria. It is used in treatment of uncomplicated urinary tract infections. No stability indicating analytical method has been reported for BFX. Also stress degradation studies of Balofloxacin were...

A stability indicating high-performance thin-layer chromatographic (HPTLC) method was developed using aluminum plates pre-coated with silica gel 60 F254 as the stationary phase and toluene: acetone: water (1.5:7.5:1.0, v/v/v) as the mobile phase with detection wavelength 277 nm. Thiocolchicoside was subjected to degradation in alkaline, acidic, oxi...

An accurate, specific and precise HPTLC method has been developed for the simultaneous estimation of Budesonide and Levalbuterol hydrochloride in their combined pharmaceutical dosage form. The chromatographic separation of Budesonide and Levalbuterol Hydrochloride was performed using aluminium plate precoated with silica gel 60 F 254 as stationary...

A simple, sensitive and pH independent spectrophotometric method has been developed for the determination of pravastatin sodium in pharmaceutical formulations. The method is based on the measurement of absorbance at isosbestic point. Isosbestic point for pravastatin sodium was observed at 249 nm and absorbances were measured at same wavelength. The...

A simple, economic and precise RP-HPLC method has been developed and validated for simultaneous estimation of thiocolchicoside (THC) and diclofenac (DCF) both in bulk drug and in capsule formulation. Reversed-phase chromatography was performed on a C 18 Phenomenex-Gemini column with mobile phase acetonitrile: water (70:30 % v/v, adjusted at pH 3.0)...

A derivative spectrophotometric procedure has been established for the simultaneous determination of etoricoxib and paracetamol in combined synthetic mixtures and pharmaceutical formulations. The method consists of the utilization of second derivative absorption spectra of synthetic mixture in sodium hydroxide solution (0.1N) and determining zero c...